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Intervenciones farmacológicas para reducir la pérdida sanguínea y la necesidad de transfusión de sangre en la resección hepática

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Referencias

Referencias de los estudios incluidos en esta revisión

Ir a:

Lentschener 1999 {published data only}

Lentschener C, Benhamou D, Mercier FJ, Boyer‐Neumann C, Naveau S, Smadja C, et al. Aprotinin reduces blood loss in patients undergoing elective liver resection. Anesthesia and Analgesia 1997;84(4):875‐81.
Lentschener C, Li H, Franco D, Mercier FJ, Lu H, Soria J, et al. Intraoperatively‐administered aprotinin and survival after elective liver resection for colorectal cancer metastasis: A preliminary study. Fibrinolysis & Proteolysis 1999;13(1):39‐45.

Lodge 2005 {published data only}

Lodge JP, Jonas S, Oussoultzoglou E, Malago M, Jayr C, Cherqui D, et al. Recombinant coagulation factor VIIa in major liver resection: a randomized, placebo‐controlled, double‐blind clinical trial. Anesthesiology 2005;102(2):269‐75.

Shao 2006 {published data only}

Shao YF, Yang JM, Chau GY, Sirivatanauksorn Y, Zhong SX, Erhardtsen E, et al. Safety and hemostatic effect of recombinant activated factor VII in cirrhotic patients undergoing partial hepatectomy: a multicenter, randomized, double‐blind, placebo‐controlled trial. American Journal of Surgery 2006;191(2):245‐9.

Shimada 1994 {published data only}

Shimada M, Matsumata T, Kamakura T, Hayashi H, Urata K, Sugimachi K. Modulation of coagulation and fibrinolysis in hepatic resection: a randomized prospective control study using antithrombin III concentrates. Thrombosis Research 1994;74(2):105‐14.

Wong 2003 {published data only}

Wong AY, Irwin MG, Hui TW, Fung SK, Fan ST, Ma ES. Desmopressin does not decrease blood loss and transfusion requirements in patients undergoing hepatectomy. Canadian Journal of Anaesthesia 2003;50(1):14‐20.

Wu 2006 {published and unpublished data}

Wu CC, Ho WM, Cheng SB, Yeh DC, Wen MC, Liu TJ, et al. Perioperative parenteral tranexamic acid in liver tumor resection: a prospective randomized trial toward a "blood transfusion"‐free hepatectomy. Annals of Surgery 2006;243(2):173‐80.

Referencias adicionales

Ir a:

Belghiti 1993

Belghiti J, Kabbej M, Sauvanet A, Vilgrain V, Panis Y, Fekete F. Drainage after elective hepatic resection. A randomized trial. Annals of Surgery 1993;218(6):748‐53.

Boutron 2008

Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P. Methods and processes of the CONSORT Group: example of an extension for trials assessing nonpharmacologic treatments. Annals of Internal Medicine 2008;148(4):W60‐W66. [PUBMED: 18283201]

Chouker 2004

Chouker A, Schachtner T, Schauer R, Dugas M, Lohe F, Martignoni A, et al. Effects of Pringle manoeuvre and ischaemic preconditioning on haemodynamic stability in patients undergoing elective hepatectomy: a randomized trial. British Journal of Anaesthesia 2004;93(2):204‐11.

DeMets 1987

DeMets DL. Methods for combining randomized clinical trials: strengths and limitations. Statistics in Medicine 1987;6(3):341‐50.

DerSimonian 1986

DerSimonian R, Laird N. Meta‐analysis in clinical trials. Controlled Clinical Trials 1986;7(3):177‐88.

Egger 1997

Egger M, Davey SG, Schneider M, Minder C. Bias in meta‐analysis detected by a simple, graphical test. BMJ (Clinical Research Ed.) 1997;315(7109):629‐34.

Frilling 2005

Frilling A, Stavrou GA, Mischinger HJ, de Hemptinne B, Rokkjaer M, Klempnauer J, et al. Effectiveness of a new carrier‐bound fibrin sealant versus argon beamer as haemostatic agent during liver resection: a randomised prospective trial. Langenbecks Archives of Surgery 2005;390(2):114‐20.

Gluud 2009

Gluud C, Nikolova D, Klingenberg SL, Whitfield K, Alexakis N, Als‐Nielsen B, et al. Cochrane Hepato‐Biliary Group. About The Cochrane Collaboration (Cochrane Review Groups (CRGs)) 2009, Issue 3. Art. No.: LIVER.

Gomez 2008

Gomez D, Morris‐Stiff G, Wyatt J, Toogood GJ, Lodge JP, Prasad KR. Surgical technique and systemic inflammation influences long‐term disease‐free survival following hepatic resection for colorectal metastasis. Journal of Surgical Oncology 2008;98(5):371‐6. [PUBMED: 18646038]

Gurusamy 2008

Gurusamy KS, Osmani B, Sharma D, Davidson BR. Non‐surgical interventions to decrease blood loss and blood transfusion requirements for liver resection. Cochrane Database of Systematic Reviews 2008, Issue 3. [DOI: 10.1002/14651858.CD007338]

Gurusamy 2009a

Gurusamy KS, Kumar Y, Sharma D, Davidson BR. Vascular occlusion for elective liver resections. Cochrane Database of Systematic Reviews 2009, Issue 1. [DOI: 10.1002/14651858.CD006409.pub2]

Gurusamy 2009b

Gurusamy KS, Pamecha V, Davidson BR. Topical haemostatic agents in liver resection. Cochrane Database of Systematic Reviews Issue under preparation.

Gurusamy 2009c

Gurusamy KS, Li J, Sharma D, Davidson BR. Cardiopulmonary interventions to decrease blood loss and blood transfusion requirements for liver resection. Cochrane Database of Systematic Reviews 2009, Issue 4. [DOI: 10.1002/14651858.CD007338]

HES 2005

Hospital Episode Statistics. Main operations. 3 character: 2004‐05. http://www.hesonline.nhs.uk/Ease/servlet/ContentServer?siteID=1937&categoryID=205 (accessed 19 March 2009).

Higgins 2002

Higgins JPT, Thompson SG. Quantifying heterogeneity in a meta‐analysis. Statistics in Medicine 2002;21(11):1539‐58.

Higgins 2008

Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.0 [updated February 2008]. The Cochrane Collaboration, 2008. Available from www.cochrane‐handbook.org.

Ibrahim 2006

Ibrahim S, Chen CL, Lin CC, Yang CH, Wang CC, Wang SH, et al. Intraoperative blood loss is a risk factor for complications in donors after living donor hepatectomy. Liver Transplantation 2006;12(6):950‐7.

Kitagawa 2001

Kitagawa K, Taniguchi H, Mugitani T, Koh T, Obayashi T, Kunishima S, et al. Safety and advantage of perioperative autologous blood transfusion in hepatic resection for hepatocellular carcinoma. Anticancer Research 2001;21(5):3663‐7.

Kjaergard 2001

Kjaergard LL, Villumsen J, Gluud C. Reported methodologic quality and discrepancies between large and small randomized trials in meta‐analyses. Annals of Internal Medicine 2001;135(11):982‐9.

Macaskill 2001

Macaskill P, Walter SD, Irwig L. A comparison of methods to detect publication bias in meta‐analysis. Statistics in Medicine 2001;20(4):641‐54.

Moher 1998

Moher D, Pham B, Jones A, Cook DJ, Jadad AR, Moher M, et al. Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta‐analyses?. Lancet 1998;352(9128):609‐13.

Moher 2001

Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel‐group randomised trials. Lancet 2001;357(9263):1191‐4. [PUBMED: 11323066]

Newell 1992

Newell DJ. Intention‐to‐treat analysis: implications for quantitative and qualitative research. International Journal of Epidemiology 1992;21(5):837‐41.

Poon 2001

Poon RT, Fan ST, Lo CM, Ng IO, Liu CL, Lam CM, et al. Improving survival results after resection of hepatocellular carcinoma: a prospective study of 377 patients over 10 years. Annals of Surgery 2001;234(1):63‐70. [PUBMED: 11420484]

RevMan 2008 [Computer program]

The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 5.0. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2008.

Royle 2003

Royle P, Milne R. Literature searching for randomized controlled trials used in Cochrane reviews: rapid versus exhaustive searches. International Journal of Technology Assessment in Health Care 2003;19(4):591‐603.

Schulz 1995

Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995;273(5):408‐12.

Shimada 1998

Shimada M, Takenaka K, Fujiwara Y, Gion T, Shirabe K, Yanaga K, et al. Risk factors linked to postoperative morbidity in patients with hepatocellular carcinoma. The British Journal of Surgery 1998;85(2):195‐8.

Shinozuka 2000

Shinozuka N, Koyama I, Arai T, Numajiri Y, Watanabe T, Nagashima N, et al. Autologous blood transfusion in patients with hepatocellular carcinoma undergoing hepatectomy. American Journal of Surgery 2000;179(1):42‐5.

StatsDirect 2.7 [Computer program]

StatsDirect Ltd. StatsDirect Statistical software Version 2.7.2. StatsDirect Ltd, 2008.

Strasberg 2000

Strasberg SM, Belghiti J, Clavien PA, Gadzijev E, Garden JO, Lau WY, et al. The Brisbane 2000 terminology of liver anatomy and resections. HPB Surgery 2000;2(3):333‐9.

Sweeting 2004

Sweeting MJ, Sutton AJ, Lambert PC. What to add to nothing? Use and avoidance of continuity corrections in meta‐analysis of sparse data. Statistics in Medicine 2004;23(9):1351‐75.

Wang 2006

Wang WD, Liang LJ, Huang XQ, Yin XY. Low central venous pressure reduces blood loss in hepatectomy. World Journal of Gastroenterology 2006;12(6):935‐9.

Wood 2008

Wood L, Egger M, Gluud LL, Schulz KF, Juni P, Altman DG, et al. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta‐epidemiological study. BMJ (Clinical Research Ed.) 2008;336(7644):601‐5. [PUBMED: 18316340]

Yoshimura 2004

Yoshimura Y, Kubo S, Shirata K, Hirohashi K, Tanaka H, Shuto T, et al. Risk factors for postoperative delirium after liver resection for hepatocellular carcinoma. World Journal of Surgery 2004;28(10):982‐6.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Lentschener 1999

Methods

Randomised clinical trial

Sequence generation: adequate.
Allocation concealment: unclear.
Blinding: adequate.
Incomplete outcome data addressed: inadequate.
Free of selective reporting: inadequate.
Free of other bias: inadequate.

Participants

Country: France.
Number randomised: 109.
Post‐randomisation drop‐outs: 12 (11%) (see notes).
Mean age: 53.5 years.
Females: 45 (46.4%).
Major liver resections: 63 (64.9%).
Cirrhotic livers: not stated.

Inclusion criteria:

  1. More than18 years.

  2. Elective liver resection.

Exclusion criteria:

  1. Allergy to aprotinin.

  2. Pregnancy.

  3. Bleeding disorder ‐ inherited or due to aspirin or dipyridamole use within 10 days before the operation or due to anticoagulation therapy that could not be interrupted.

  4. Preoperative fibrinolysis requiring an intraoperative antifibrinolytic treatment.

  5. Preoperative platelet count below 6 x l04 mm3.

  6. Prothrombin time (PT) < 50%.

  7. Previous venous or arterial thrombosis or any biological abnormality likely to induce thrombosis,

  8. Impaired renal function.

Interventions

Participants were randomly assigned to two groups.

Group 1: Aprotinin (n = 48).
Group 2: control (n = 49).

Further details of intervention:
5 million KIU per hour until skin closure (loading dose of 2 million KIU at induction)

Other details:
Vascular occlusion: intermittent clamping.
Method of parenchymal transection: clamp crush technique.
Management of raw surface: absorbable clips.
Other co‐interventions to decrease blood loss: none reported.

Outcomes

The outcome measures were mortality, survival (one year survival and 28 months survival in patients with colorectal liver metastases), peri‐operative morbidity, transfusion requirements, blood loss and liver function tests.

Notes

12 patients from both groups (individual groups not stated) in whom tumour could not be removed (n = 6), had wrong operative histological assessment (n = 5), and thoracotomy (n = 1) were excluded from analysis.

Attempts to contact the authors in November 2008 were unsuccessful.

Risk of bias

Bias

Authors' judgement

Support for judgement

Adequate sequence generation?

Low risk

Quote: "Adult patients scheduled for elective liver resection performed through abdominal incision were assigned in a double‐blind fashion, by means of a computer‐generated random code ....."

Allocation concealment?

Unclear risk

Unclear.

Blinding?
All outcomes

Low risk

Quote: "Adult patients scheduled for elective liver resection performed through abdominal incision were assigned in a double‐blind fashion ....."; "An identical‐appearing placebo was prepared by a nurse not involved in latter assessment."

Incomplete outcome data addressed?
All outcomes

High risk

Comment: There were 12 post‐randomisation drop‐outs. The reasons for these drop‐outs could be related to the treatment effect.

Free of selective reporting?

High risk

Comment: Important outcomes such as liver failure were not reported.

Free of baseline imbalance?

Unclear risk

Unclear.

Free of early stopping bias?

Low risk

Comment: The trialists recruited the intended number of patients.

Free of academic bias?

Low risk

Comment: There were no previously published trials of same comparisons by the author.

Free of sponsor bias?

High risk

Quote: "This study was conducted independently of, but partially supported
by Assistance Publique‐Hopitaux de Paris, Bayer Pharma France, ....."

Lodge 2005

Methods

Randomised clinical trial

Sequence generation: adequate.
Allocation concealment: adequate.
Blinding: adequate.
Incomplete outcome data addressed: inadequate.
Free of selective reporting: inadequate.
Free of other bias: inadequate.

Participants

Country: France, Germany, Spain, United Kingdom.
Number randomised: 204.
Post‐randomisation drop‐out: 19 (9.3%) (see notes).
Mean age: 56.5 years.
Females: 92 (49.7%).
Major liver resections: not stated.
Cirrhotic livers: 0 (0%).

Inclusion criteria:

  1. Adults.

  2. Non‐cirrhotic.

  3. Liver resections.

Exclusion criteria:

  1. Hereditary bleeding disorders.

  2. Planned use of autologous blood transfusion.

  3. Ant‐coagulation therapy within 48 hours before hepatectomy.

  4. Use of tissue glue.

  5. Hemodilution therapy.

  6. Hemostatic drugs for prophylactic purposes.

  7. Renal insufficiency requiring dialysis.

  8. Portal vein or deep vein thrombosis within the preceding 6 months.

  9. Severe cardiovascular disease or myocardial/pulmonary infarction or stroke within the preceding 6 months.

  10. Active bleeding.

  11. Use of nonsteroidal antiinflammatory drugs within 7 days before surgery.

Interventions

Participants were randomly assigned to three groups.

Group 1: rFVIIa 80 mcg/kg (n = 59).
Group 2: rFVIIa 20 mcg/kg (n = 63).
Group 3: control (n = 63).

Further details of intervention:
IV drug 5 minutes before incision and repeated at 5 hours if anticipated operating time > 6 hours.

Other details:
Vascular occlusion: PTC (in 64.9%).
Method of parenchymal transection: not stated.
Management of raw surface: not stated.
Other co‐interventions to decrease blood loss: none reported.

Outcomes

The outcome measures were mortality, transfusion requirements, peri‐operative morbidity, operating time, and blood loss.

Notes

19 patients from all three groups (individual groups not stated) in whom drug was not administered (n = 4) and in those who did not undergo liver resection after the drug was administered (n = 15) were excluded from analysis.

Attempts to contact the authors in November 2008 were unsuccessful.

Risk of bias

Bias

Authors' judgement

Support for judgement

Adequate sequence generation?

Low risk

Quote: "Randomization was computer‐generated and was performed after patient eligibility assessments on the day of surgery by means of a central interactive voice response system set up by Novo Nordisk A/S."

Allocation concealment?

Low risk

Quote: "Randomization was computer‐generated and was performed after patient eligibility assessments on the day of surgery by means of a central interactive voice response system set up by Novo Nordisk A/S."

Blinding?
All outcomes

Low risk

Quote: "To maintain blinding, an equal volume of trial drug per body weight was administered to all patients, irrespective of treatment group allocation."

Incomplete outcome data addressed?
All outcomes

High risk

Comment: 19 patients were excluded post‐randomisation. This could be related to the treatment effect.

Free of selective reporting?

High risk

Comment: Important outcomes such as liver failure were not reported.

Free of baseline imbalance?

Low risk

Yes.

Free of early stopping bias?

Low risk

Comment: The trialists recruited the intended number of patients.

Free of academic bias?

Low risk

Comment: There were no previously published trials of same comparisons by the author.

Free of sponsor bias?

High risk

Quote: "The authors thank the patients and the hospital staff participating in the trial, as well as Allan Blemings, M.Sc. (Statistician), and Karsten Soendergaard, M.Sc.
(Clinical Researcher), both at Novo Nordisk A/S, Copenhagen, Denmark."

Shao 2006

Methods

Randomised clinical trial

Sequence generation: unclear.
Allocation concealment: unclear.
Blinding: adequate.
Incomplete outcome data addressed: inadequate.
Free of selective reporting: inadequate.
Free of other bias: unclear.

Participants

Country: China, Thailand, Taiwan.
Number randomised: 235
Post‐randomisation drop‐outs: 14 (6%) (see notes).
Mean age: 51.7 years.
Females: 38 (17.2%).
Major liver resections: not stated.
Cirrhotic livers: 235 (100%).

Inclusion criteria:

  1. > 21 years of age.

  2. Cirrhotic patients.

  3. Elective liver resection.

Exclusion criteria:

  1. Portal vein thrombosis or deep vein thrombosis.

  2. Severe cardiovascular disease (previous myocardial/pulmonary infarction or stroke).

  3. Renal insufficiency requiring dialysis.

  4. Anticoagulation therapy within 48 hours of surgery.

  5. Life expectancy of < 1 month owing to known metastasis.

  6. Other major abdominal surgery planned during the partial hepatectomy.

  7. Synchronous liver and intestinal resections.

  8. Previous partial hepatectomy.

Interventions

Participants were randomly assigned to three groups.

Group 1: rFVIIa 100 mcg/kg (n = 74).
Group 2: rFVIIa 50 mcg/kg (n = 71).
Group 3: control (n = 76).

Further details of intervention:
IV drug every 2 hours starting 10 minutes before incision (maximum 4 doses).

Other details:
Vascular occlusion: not stated.
Method of parenchymal transection: not stated.
Management of raw surface: not stated.
Other co‐interventions to decrease blood loss: none reported.

Outcomes

The outcome measures were mortality, transfusion requirements, peri‐operative morbidity, operating time, and blood loss.

Notes

12 patients from all three groups (individual groups not stated) who did not undergo liver resection (n = 11) and who withdrew consent (n = 1) were excluded from analysis. The data of 2 patients in the placebo group were lost. Thus only 221 patients were included for analysis.

Attempts to contact the authors in November 2008 were unsuccessful.

Risk of bias

Bias

Authors' judgement

Support for judgement

Adequate sequence generation?

Unclear risk

Unclear.

Allocation concealment?

Unclear risk

Unclear.

Blinding?
All outcomes

Low risk

Quote: "Within 10 minutes before the first skin cut, a bolus dose of rFVIIa 50 or 100 g/kg or placebo was administered intravenously over the course of 2 minutes...."

Incomplete outcome data addressed?
All outcomes

High risk

Comment: 14 patients were excluded post‐randomisation. This could be related to the treatment effect.

Free of selective reporting?

High risk

Comment: Important outcomes such as liver failure were not reported.

Free of baseline imbalance?

Unclear risk

Unclear.

Free of early stopping bias?

Low risk

Comment: The trialists recruited the intended number of patients.

Free of academic bias?

Low risk

Comment: There were no previously published trials of same comparisons by the author.

Free of sponsor bias?

Unclear risk

Unclear.
Shimada 1994

Methods

Randomised clinical trial

Sequence generation: unclear.
Allocation concealment: unclear.
Blinding: inadequate.
Incomplete outcome data addressed: unclear.
Free of selective reporting: inadequate.
Free of other bias: inadequate.

Participants

Country: Japan.
Number randomised: 24.
Post‐randomisation drop‐outs: not stated.
Mean age: 62.7 years.
Females: 4 (16.7%).
Major liver resections: 10 (41.7%).
Cirrhotic livers: 12 (50%).

Inclusion criteria:

  1. HCC.

  2. Liver resection.

Interventions

Participants were randomly assigned to two groups.

Group 1: antithrombin (n = 13).
Group 2: control (n = 11).

Further details of intervention
1500 units IV 3 doses (just before operation, before liver parenchymal transection, and just after operation).

Other details:
Vascular occlusion: not stated.
Method of parenchymal transection: not stated.
Management of raw surface: not stated.
Other co‐interventions to decrease blood loss: none reported.

Outcomes

The outcome measures were liver failure, transfusion requirements, peri‐operative morbidity, operating time, blood loss, and liver function tests.

Notes

Attempts to contact the authors in November 2008 were unsuccessful.

Risk of bias

Bias

Authors' judgement

Support for judgement

Adequate sequence generation?

Unclear risk

Unclear.

Allocation concealment?

Unclear risk

Unclear.

Blinding?
All outcomes

High risk

No.

Incomplete outcome data addressed?
All outcomes

Unclear risk

Unclear.

Free of selective reporting?

High risk

Comment: Important outcomes such as mortality were not reported.

Free of baseline imbalance?

High risk

Comment: There was statisitically significantly more patients with cirrhosis in the intervention group.

Free of early stopping bias?

Unclear risk

Unclear.

Free of academic bias?

Low risk

Comment: There were no previously published trials of same comparisons by the author.

Free of sponsor bias?

Unclear risk

Unclear.
Wong 2003

Methods

Randomised clinical trial

Sequence generation: unclear.
Allocation concealment: unclear.
Blinding: adequate.
Incomplete outcome data addressed: adequate.
Free of selective reporting: inadequate.
Free of other bias: unclear.

Participants

Country: China.
Number randomised: 60.
Post‐randomisation drop‐outs: 0.
Mean age: 51.2 years.
Females: 23 (38.3%).
Major liver resections: not stated.
Cirrhotic livers: 23 (38.3%).

Inclusion criteria:
Elective liver resection.

Exclusion criteria

  1. Coronary artery disease.

  2. Congenital or acquired coagulation disorders other than liver cirrhosis.

  3. Serum sodium level < 130 mmol/l.

  4. NSAID or aspirin seven days of scheduled surgery.

  5. History of thrombovascular disorders or pulmonary thromboembolism.

Interventions

Participants were randomly assigned to two groups.

Group 1: desmopressin (n = 30).
Group 2: control (n = 30).

Further details of intervention:
single dose IV desmopressin 0.3 mcg/kg just after induction.

Other details:
Vascular occlusion: PTC in 17 and 18 patients in the two groups.
Method of parenchymal transection: not stated.
Management of raw surface: not stated.
Other co‐interventions to decrease blood loss: none reported.

Outcomes

The outcome measures were transfusion requirements, operating time, and blood loss.

Notes

Attempts to contact the authors in November 2008 were unsuccessful.

Risk of bias

Bias

Authors' judgement

Support for judgement

Adequate sequence generation?

Unclear risk

Unclear.

Allocation concealment?

Unclear risk

Quote: "Patient randomization was by drawing a sealed envelope specifying a prescription for either desmopressin or placebo...."

Comment: It is not clear whether the authors used opaque envelopes.

Blinding?
All outcomes

Low risk

Quote: "Patient randomization was by drawing a sealed envelope specifying a prescription for either desmopressin or placebo, which was then prepared by an
independent investigator and blinded to the patient, attending anesthesiologist and surgeon.

Incomplete outcome data addressed?
All outcomes

Low risk

Comment: There were no post‐randomisation drop‐outs.

Free of selective reporting?

High risk

Comment: Important outcomes such as liver failure were not reported.

Free of baseline imbalance?

Unclear risk

Unclear.

Free of early stopping bias?

Unclear risk

Unclear.

Free of academic bias?

Low risk

Comment: There were no previously published trials of same comparisons by the author.

Free of sponsor bias?

Low risk

Quote: "This study was supported by a Hong Kong University CRCG grant (10202115/20013/20100/323/01)."
Wu 2006

Methods

Randomised clinical trial

Sequence generation: adequate.
Allocation concealment: unclear.
Blinding: adequate.
Incomplete outcome data addressed: inadequate.
Free of selective reporting: inadequate.
Free of other bias: unclear.

Participants

Country: China.
Number randomised: 217.
Post‐randomisation drop‐outs: 3 (1.4%) (see notes).
Mean age: 59.5 years.
Females: 57 (26.6%).
Major liver resections: 38 (17.8%).
Cirrhotic livers: 110 (51.4%).

Inclusion criteria:
Liver resection for tumours.

Exclusion criteria:

  1. Hb < 8 gm/ dl.

  2. Anaemia.

  3. End‐stage renal failure.

  4. Emergency surgery.

  5. Resection performed under cardiopulmonary bypass.

Interventions

Participants were randomly assigned to two groups.

Group 1: tranexamic acid (n = 108).
Group 2: control (n = 106).

Further details of intervention:
250 mg four times a day for 3 days starting just before operation (first dose = 500 mg).

Other details:
Vascular occlusion: intermittent PTC or selective intermittent occlusion.
Method of parenchymal transection: clamp‐crush method.
Management of raw surface: ligatures and sutures.
Other co‐interventions to decrease blood loss: none reported.

Outcomes

The outcome measures were mortality, transfusion requirements, operating time, hospital stay, and blood loss.

Notes

1 patient from intervention group and 2 patients from control group in whom liver resection was not completed because of presence of peritoneal dissemination or because the tumours were present in both lobes of the liver were excluded from analysis.

Authors replied to questions related to methodological quality and mortality in November 2008.

Risk of bias

Bias

Authors' judgement

Support for judgement

Adequate sequence generation?

Low risk

Quote: "The random sequence was made by random number table." (author replies)

Allocation concealment?

Unclear risk

Quote: "The randomization was double‐blinded in a sealed envelope."

Comment: It is not clear whether the authors used opaque envelopes.

Blinding?
All outcomes

Low risk

Quote: "...a similar volume of normal saline was used as a placebo at the same
time interval as TA injection. Neither surgeons nor medical staffs knew whether patients were enrolled in group A or group B."

Incomplete outcome data addressed?
All outcomes

High risk

Comment: 3 patients were excluded post‐randomisation. The outcomes could be measured and reported in these patients. But these were not reported.

Free of selective reporting?

High risk

Comment: Important outcomes such as liver failure were not reported.

Free of baseline imbalance?

Low risk

Yes.

Free of early stopping bias?

Unclear risk

Unclear.

Free of academic bias?

Low risk

Comment: There were no previously published trials of same comparisons by the author.

Free of sponsor bias?

Low risk

Quote: "Supported in part by a grant from National Science Council, Taiwan (No.
92‐2314‐B‐075A‐006)."

CUSA = cavitron ultrasonic surgical aspirator
CVP = central venous pressure
MAP = mean arterial pressure
PTC = portal triad clamping

Data and analyses

Open in table viewer
Comparison 1. Intervention versus control

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality Show forest plot

4

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only
Analysis 1.1
Comparison 1 Intervention versus control, Outcome 1 Mortality.

Comparison 1 Intervention versus control, Outcome 1 Mortality.

1.1 Aprotinin versus control

1

37

Risk Ratio (M‐H, Fixed, 95% CI)

1.18 [0.18, 7.48]

1.2 Tranexamic acid versus control

1

217

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.3 Recombinant VIIa (rFVIIa) high dose (80 to 100 mcg/kg) versus control

2

272

Risk Ratio (M‐H, Fixed, 95% CI)

0.79 [0.18, 3.51]

1.4 Recombinant VIIa (rFVIIa) low dose (20 to 50 mcg/kg) versus control

2

273

Risk Ratio (M‐H, Fixed, 95% CI)

1.59 [0.43, 5.89]

1.5 Recombinant VIIa (rFVIIa) high dose (80 to 100 mcg/kg) versus low dose (20 to 50 mcg/kg)

2

267

Risk Ratio (M‐H, Fixed, 95% CI)

0.46 [0.10, 2.08]

2 Survival Show forest plot

Other data

No numeric data
Analysis 1.2

Study

Aprotinin versus control

Lentschener 1999

In this trial, survival was reported for patients undergoing liver resection for colorectal liver metastases. The exact number of patients in each group was not stated and survival outcomes could not be included for meta‐analysis. The one‐year survival in patients with colorectal liver metastases was statistically greater in the aprotinin group than the control group. However, the survival advantage was lost at 28 months.

Comparison 1 Intervention versus control, Outcome 2 Survival.

2.1 Aprotinin versus control

Other data

No numeric data

3 Liver failure Show forest plot

Other data

No numeric data
Analysis 1.3

Study

Antithrombin

Control

P value

Antithrombin III versus control

Shimada 1994

1/13 (7.7%)

1/11 (9.1%)

P > 0.9999

Comparison 1 Intervention versus control, Outcome 3 Liver failure.

3.1 Antithrombin III versus control

Other data

No numeric data

4 Peri‐operative morbidity

Other data

No numeric data

4.1 See analysis 2

Other data

No numeric data

5 Number requiring allogeneic blood transfusion Show forest plot

5

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only
Analysis 1.5
Comparison 1 Intervention versus control, Outcome 5 Number requiring allogeneic blood transfusion.

Comparison 1 Intervention versus control, Outcome 5 Number requiring allogeneic blood transfusion.

5.1 Aprotinin versus control

1

97

Risk Ratio (M‐H, Fixed, 95% CI)

0.43 [0.21, 0.89]

5.2 Tranexamic acid versus control

1

214

Risk Ratio (M‐H, Fixed, 95% CI)

0.03 [0.00, 0.46]

5.3 Desmopressin versus control

1

59

Risk Ratio (M‐H, Fixed, 95% CI)

0.58 [0.15, 2.21]

5.4 Recombinant VIIa (rFVIIa) high dose (80 to 100 mcg/kg) versus control

2

272

Risk Ratio (M‐H, Fixed, 95% CI)

0.86 [0.62, 1.20]

5.5 Recombinant VIIa (rFVIIa) low dose (20 to 50 mcg/kg) versus control

2

273

Risk Ratio (M‐H, Fixed, 95% CI)

1.24 [0.94, 1.64]

5.6 Recombinant VIIa (rFVIIa) high dose (80 to 100 mcg/kg) versus low dose (20 to 50 mcg/kg)

2

267

Risk Ratio (M‐H, Fixed, 95% CI)

0.69 [0.51, 0.94]

6 Red cell transfusion Show forest plot

4

Std. Mean Difference (IV, Fixed, 95% CI)

Subtotals only
Analysis 1.6
Comparison 1 Intervention versus control, Outcome 6 Red cell transfusion.

Comparison 1 Intervention versus control, Outcome 6 Red cell transfusion.

6.1 Desmopressin versus control

1

59

Std. Mean Difference (IV, Fixed, 95% CI)

‐0.31 [‐0.82, 0.21]

6.2 Recombinant VIIa (rFVIIa) high dose (80 to 100 mcg/kg) versus control

2

272

Std. Mean Difference (IV, Fixed, 95% CI)

0.01 [‐0.23, 0.24]

6.3 Recombinant VIIa (rFVIIa) high dose (20 to 50 mcg/kg) versus control

2

269

Std. Mean Difference (IV, Fixed, 95% CI)

0.19 [‐0.05, 0.43]

6.4 Recombinant VIIa (rFVIIa) high dose (80 to 100 mcg/kg) versus low dose (20 to 50 mcg/kg)

2

267

Std. Mean Difference (IV, Fixed, 95% CI)

‐0.19 [‐0.43, 0.05]

6.5 Antithrombin versus control

1

24

Std. Mean Difference (IV, Fixed, 95% CI)

0.07 [‐0.73, 0.88]

7 Operating time (minutes) Show forest plot

6

Mean Difference (IV, Fixed, 95% CI)

Subtotals only
Analysis 1.7
Comparison 1 Intervention versus control, Outcome 7 Operating time (minutes).

Comparison 1 Intervention versus control, Outcome 7 Operating time (minutes).

7.1 Aprotinin versus control

1

97

Mean Difference (IV, Fixed, 95% CI)

‐1.0 [‐30.08, 28.08]

7.2 Tranexamic acid versus control

1

214

Mean Difference (IV, Fixed, 95% CI)

‐52.20 [‐86.15, ‐18.25]

7.3 Desmopressin versus control

1

59

Mean Difference (IV, Fixed, 95% CI)

‐30.0 [‐112.69, 52.69]

7.4 Recombinant VIIa (rFVIIa) high dose (80 to 100 mcg/kg) versus control

2

272

Mean Difference (IV, Fixed, 95% CI)

‐16.80 [‐40.42, 6.81]

7.5 Recombinant VIIa (rFVIIa) high dose (20 to 50 mcg/kg) versus control

2

269

Mean Difference (IV, Fixed, 95% CI)

7.38 [‐18.41, 33.16]

7.6 Recombinant VIIa (rFVIIa) high dose (80 to 100 mcg/kg) versus low dose (20 to 50 mcg/kg)

2

267

Mean Difference (IV, Fixed, 95% CI)

‐24.29 [‐48.84, 0.27]

7.7 Antithrombin versus control

1

24

Mean Difference (IV, Fixed, 95% CI)

‐28.0 [‐79.80, 23.80]

8 Hospital stay (days) Show forest plot

Other data

No numeric data
Analysis 1.8

Study

Tranexamic acid Mean (standard deviation)

ControlMean (standard deviation)

P value

Tranexamic acid versus control

Wu 2006

8 (7.66)

9 (7.66)

0.34

Comparison 1 Intervention versus control, Outcome 8 Hospital stay (days).

8.1 Tranexamic acid versus control

Other data

No numeric data

9 Transection blood loss (ml) Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Subtotals only
Analysis 1.9
Comparison 1 Intervention versus control, Outcome 9 Transection blood loss (ml).

Comparison 1 Intervention versus control, Outcome 9 Transection blood loss (ml).

9.1 Tranexamic acid versus control

1

214

Mean Difference (IV, Fixed, 95% CI)

‐260.0 [‐434.99, ‐85.01]

9.2 Desmopressin versus control

1

59

Mean Difference (IV, Fixed, 95% CI)

‐45.0 [‐626.86, 536.86]

10 Operative blood loss (ml) Show forest plot

6

Mean Difference (IV, Fixed, 95% CI)

Subtotals only
Analysis 1.10
Comparison 1 Intervention versus control, Outcome 10 Operative blood loss (ml).

Comparison 1 Intervention versus control, Outcome 10 Operative blood loss (ml).

10.1 Aprotinin versus control

1

97

Mean Difference (IV, Fixed, 95% CI)

‐434.00 [‐873.67, 1.67]

10.2 Tranexamic acid versus control

1

214

Mean Difference (IV, Fixed, 95% CI)

‐300.0 [‐502.05, ‐97.95]

10.3 Desmopressin versus control

1

59

Mean Difference (IV, Fixed, 95% CI)

32.5 [‐695.69, 760.69]

10.4 Recombinant VIIa (rFVIIa) high dose (80 to 100 mcg/kg) versus control

2

272

Mean Difference (IV, Fixed, 95% CI)

‐156.86 [‐427.71, 113.99]

10.5 Recombinant VIIa (rFVIIa) low dose (20 to 50 mcg/kg) versus control

2

273

Mean Difference (IV, Fixed, 95% CI)

138.29 [‐166.99, 443.57]

10.6 Recombinant VIIa (rFVIIa) high dose (80 to 100 mcg/kg) versus low dose (20 to 50 mcg/kg)

2

267

Mean Difference (IV, Fixed, 95% CI)

‐299.54 [‐577.54, ‐21.54]

10.7 Antithrombin versus control

1

24

Mean Difference (IV, Fixed, 95% CI)

463.00 [‐326.67, 1252.67]

11 Bilirubin (micromol/litre) Show forest plot

Other data

No numeric data
Analysis 1.11

Study

Antithrombin III

Mean (standard deviation)

Control

Mean (standard deviation)

Mean difference

(95% confidence intervals)

Statistical signficance

Antithrombin III versus control

Shimada 1994

2.1(1.1)

2.5(1.3)

‐0.40 (‐1.37 to 0.57)

P = 0.42

Comparison 1 Intervention versus control, Outcome 11 Bilirubin (micromol/litre).

11.1 Antithrombin III versus control

Other data

No numeric data

12 Prothrombin activity (percentage of normal activity) Show forest plot

Other data

No numeric data
Analysis 1.12

Study

Aprotinin

Mean (standard deviation)

Control

Mean (standard deviation)

Mean difference(95% confidence intervals)

Statistical significance

Aprotinin versus control

Lentschener 1999

63(12)

63(15)

0 (‐5.4 to 5.4)

P = 1.00

Comparison 1 Intervention versus control, Outcome 12 Prothrombin activity (percentage of normal activity).

12.1 Aprotinin versus control

Other data

No numeric data

13 Aspartate transaminase (international units per litre) (peak) Show forest plot

Other data

No numeric data
Analysis 1.13

Study

Antithrombin III

Mean (standard deviation)

Control

Mean (standard deviation)

Mean difference

(95% confidence intervals)

Statistical significance

Antithrombin III versus control

Shimada 1994

170 (86.5)

177(63)

‐7.00 (‐66.98 to 52.98)

P = 0.82

Comparison 1 Intervention versus control, Outcome 13 Aspartate transaminase (international units per litre) (peak).

13.1 Antithrombin III versus control

Other data

No numeric data

14 Alanine transminase (international units per litre) (peak) Show forest plot

Other data

No numeric data
Analysis 1.14

Study

Antithrombin III

Mean (standard deviation)

Control

Mean (standard deviation)

Mean difference

(95% confidence intervals)

Statistical significance

Antithrombin III versus control

Shimada 1994

95 (39.7)

86 (39.8)

9.00 (‐22.92 to 40.92)

P = 0.58

Comparison 1 Intervention versus control, Outcome 14 Alanine transminase (international units per litre) (peak).

14.2 Antithrombin III versus control

Other data

No numeric data
Open in table viewer
Comparison 2. Peri‐operative morbidity

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Tranexamic acid versus control Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only
Analysis 2.1
Comparison 2 Peri‐operative morbidity, Outcome 1 Tranexamic acid versus control.

Comparison 2 Peri‐operative morbidity, Outcome 1 Tranexamic acid versus control.

1.1 Ascites

1

214

Risk Ratio (M‐H, Fixed, 95% CI)

0.98 [0.29, 3.29]

1.2 Intra‐abdominal abscess

1

214

Risk Ratio (M‐H, Fixed, 95% CI)

0.74 [0.26, 2.05]

1.3 Bile leak

1

214

Risk Ratio (M‐H, Fixed, 95% CI)

1.96 [0.37, 10.49]

1.4 Wound infection

1

214

Risk Ratio (M‐H, Fixed, 95% CI)

0.65 [0.11, 3.84]

1.5 Pleural effusion

1

214

Risk Ratio (M‐H, Fixed, 95% CI)

0.49 [0.05, 5.33]

2 Recombinant VIIa (rFVIIa) high dose (80 to 100 mcg/kg) versus control Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only
Analysis 2.2
Comparison 2 Peri‐operative morbidity, Outcome 2 Recombinant VIIa (rFVIIa) high dose (80 to 100 mcg/kg) versus control.

Comparison 2 Peri‐operative morbidity, Outcome 2 Recombinant VIIa (rFVIIa) high dose (80 to 100 mcg/kg) versus control.

2.1 Bile leak

1

150

Risk Ratio (M‐H, Fixed, 95% CI)

0.34 [0.01, 8.27]

2.2 Hyperamylasemia

1

150

Risk Ratio (M‐H, Fixed, 95% CI)

3.08 [0.13, 74.42]

2.3 Pleural effusion

1

150

Risk Ratio (M‐H, Fixed, 95% CI)

3.08 [0.13, 74.42]

2.4 Myocardial infarction

2

272

Risk Ratio (M‐H, Fixed, 95% CI)

3.08 [0.13, 74.42]

2.5 Pulmonary embolism

2

272

Risk Ratio (M‐H, Fixed, 95% CI)

1.05 [0.15, 7.28]

2.6 Deep vein thrombosis

1

122

Risk Ratio (M‐H, Fixed, 95% CI)

1.07 [0.16, 7.34]

2.7 Portal vein thrombosis

2

272

Risk Ratio (M‐H, Fixed, 95% CI)

0.36 [0.01, 8.56]

2.8 Mesenteric vein thrombosis

1

150

Risk Ratio (M‐H, Fixed, 95% CI)

3.08 [0.13, 74.42]

3 Recombinant VIIa (rFVIIa) low dose (20 to 50 mcg/kg) versus control Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only
Analysis 2.3
Comparison 2 Peri‐operative morbidity, Outcome 3 Recombinant VIIa (rFVIIa) low dose (20 to 50 mcg/kg) versus control.

Comparison 2 Peri‐operative morbidity, Outcome 3 Recombinant VIIa (rFVIIa) low dose (20 to 50 mcg/kg) versus control.

3.1 Bile leak

1

147

Risk Ratio (M‐H, Fixed, 95% CI)

1.07 [0.07, 16.79]

3.2 Hyperamylasemia

1

147

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.3 Pleural effusion

1

147

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.4 Myocardial infarction

2

273

Risk Ratio (M‐H, Fixed, 95% CI)

5.0 [0.24, 102.10]

3.5 Pulmonary embolism

2

273

Risk Ratio (M‐H, Fixed, 95% CI)

1.03 [0.14, 7.38]

3.6 Deep vein thrombosis

1

126

Risk Ratio (M‐H, Fixed, 95% CI)

0.2 [0.01, 4.08]

3.7 Portal vein thrombosis

2

273

Risk Ratio (M‐H, Fixed, 95% CI)

1.03 [0.15, 7.14]

3.8 Mesenteric vein thrombosis

1

147

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4 Recombinant VIIa (rFVIIa) high dose (80 to 100 mcg/kg) versus low dose (20 to 50 mcg/kg) Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only
Analysis 2.4
Comparison 2 Peri‐operative morbidity, Outcome 4 Recombinant VIIa (rFVIIa) high dose (80 to 100 mcg/kg) versus low dose (20 to 50 mcg/kg).

Comparison 2 Peri‐operative morbidity, Outcome 4 Recombinant VIIa (rFVIIa) high dose (80 to 100 mcg/kg) versus low dose (20 to 50 mcg/kg).

4.1 Bile leak

1

145

Risk Ratio (M‐H, Fixed, 95% CI)

0.32 [0.01, 7.73]

4.2 Hyperamylasemia

1

145

Risk Ratio (M‐H, Fixed, 95% CI)

2.88 [0.12, 69.55]

4.3 Pleural effusion

1

145

Risk Ratio (M‐H, Fixed, 95% CI)

2.88 [0.12, 69.55]

4.4 Myocardial infarction

2

267

Risk Ratio (M‐H, Fixed, 95% CI)

0.68 [0.11, 4.12]

4.5 Pulmonary embolism

2

267

Risk Ratio (M‐H, Fixed, 95% CI)

1.07 [0.07, 16.69]

4.6 Deep vein thrombosis

1

122

Risk Ratio (M‐H, Fixed, 95% CI)

5.33 [0.26, 108.84]

4.7 Portal vein thrombosis

2

267

Risk Ratio (M‐H, Fixed, 95% CI)

0.32 [0.01, 7.73]

4.8 Mesenteric vein thrombosis

1

145

Risk Ratio (M‐H, Fixed, 95% CI)

2.88 [0.12, 69.55]

5 Anitithrombin III versus control Show forest plot

Other data

No numeric data
Analysis 2.5

Study

Antithrombin

Control

P value

Infected intra‐abdominal collection

Shimada 1994

1/13 (7.7%)

1/11 (9.1%)

P > 0.9999

Comparison 2 Peri‐operative morbidity, Outcome 5 Anitithrombin III versus control.

5.1 Infected intra‐abdominal collection

Other data

No numeric data

Reference flow chart
Figuras y tablas -
Figure 1

Reference flow chart

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Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
Figuras y tablas -
Figure 2

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

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Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
Figuras y tablas -
Figure 3

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

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Comparison 1 Intervention versus control, Outcome 1 Mortality.
Figuras y tablas -
Analysis 1.1

Comparison 1 Intervention versus control, Outcome 1 Mortality.

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Study

Aprotinin versus control

Lentschener 1999

In this trial, survival was reported for patients undergoing liver resection for colorectal liver metastases. The exact number of patients in each group was not stated and survival outcomes could not be included for meta‐analysis. The one‐year survival in patients with colorectal liver metastases was statistically greater in the aprotinin group than the control group. However, the survival advantage was lost at 28 months.

Figuras y tablas -
Analysis 1.2

Comparison 1 Intervention versus control, Outcome 2 Survival.

Ir a la figura de la revisión

Study

Antithrombin

Control

P value

Antithrombin III versus control

Shimada 1994

1/13 (7.7%)

1/11 (9.1%)

P > 0.9999

Figuras y tablas -
Analysis 1.3

Comparison 1 Intervention versus control, Outcome 3 Liver failure.

Ir a la figura de la revisión

Comparison 1 Intervention versus control, Outcome 5 Number requiring allogeneic blood transfusion.
Figuras y tablas -
Analysis 1.5

Comparison 1 Intervention versus control, Outcome 5 Number requiring allogeneic blood transfusion.

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Comparison 1 Intervention versus control, Outcome 6 Red cell transfusion.
Figuras y tablas -
Analysis 1.6

Comparison 1 Intervention versus control, Outcome 6 Red cell transfusion.

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Comparison 1 Intervention versus control, Outcome 7 Operating time (minutes).
Figuras y tablas -
Analysis 1.7

Comparison 1 Intervention versus control, Outcome 7 Operating time (minutes).

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Study

Tranexamic acid Mean (standard deviation)

ControlMean (standard deviation)

P value

Tranexamic acid versus control

Wu 2006

8 (7.66)

9 (7.66)

0.34

Figuras y tablas -
Analysis 1.8

Comparison 1 Intervention versus control, Outcome 8 Hospital stay (days).

Ir a la figura de la revisión

Comparison 1 Intervention versus control, Outcome 9 Transection blood loss (ml).
Figuras y tablas -
Analysis 1.9

Comparison 1 Intervention versus control, Outcome 9 Transection blood loss (ml).

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Comparison 1 Intervention versus control, Outcome 10 Operative blood loss (ml).
Figuras y tablas -
Analysis 1.10

Comparison 1 Intervention versus control, Outcome 10 Operative blood loss (ml).

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Study

Antithrombin III

Mean (standard deviation)

Control

Mean (standard deviation)

Mean difference

(95% confidence intervals)

Statistical signficance

Antithrombin III versus control

Shimada 1994

2.1(1.1)

2.5(1.3)

‐0.40 (‐1.37 to 0.57)

P = 0.42

Figuras y tablas -
Analysis 1.11

Comparison 1 Intervention versus control, Outcome 11 Bilirubin (micromol/litre).

Ir a la figura de la revisión

Study

Aprotinin

Mean (standard deviation)

Control

Mean (standard deviation)

Mean difference(95% confidence intervals)

Statistical significance

Aprotinin versus control

Lentschener 1999

63(12)

63(15)

0 (‐5.4 to 5.4)

P = 1.00

Figuras y tablas -
Analysis 1.12

Comparison 1 Intervention versus control, Outcome 12 Prothrombin activity (percentage of normal activity).

Ir a la figura de la revisión

Study

Antithrombin III

Mean (standard deviation)

Control

Mean (standard deviation)

Mean difference

(95% confidence intervals)

Statistical significance

Antithrombin III versus control

Shimada 1994

170 (86.5)

177(63)

‐7.00 (‐66.98 to 52.98)

P = 0.82

Figuras y tablas -
Analysis 1.13

Comparison 1 Intervention versus control, Outcome 13 Aspartate transaminase (international units per litre) (peak).

Ir a la figura de la revisión

Study

Antithrombin III

Mean (standard deviation)

Control

Mean (standard deviation)

Mean difference

(95% confidence intervals)

Statistical significance

Antithrombin III versus control

Shimada 1994

95 (39.7)

86 (39.8)

9.00 (‐22.92 to 40.92)

P = 0.58

Figuras y tablas -
Analysis 1.14

Comparison 1 Intervention versus control, Outcome 14 Alanine transminase (international units per litre) (peak).

Ir a la figura de la revisión

Comparison 2 Peri‐operative morbidity, Outcome 1 Tranexamic acid versus control.
Figuras y tablas -
Analysis 2.1

Comparison 2 Peri‐operative morbidity, Outcome 1 Tranexamic acid versus control.

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Comparison 2 Peri‐operative morbidity, Outcome 2 Recombinant VIIa (rFVIIa) high dose (80 to 100 mcg/kg) versus control.
Figuras y tablas -
Analysis 2.2

Comparison 2 Peri‐operative morbidity, Outcome 2 Recombinant VIIa (rFVIIa) high dose (80 to 100 mcg/kg) versus control.

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Comparison 2 Peri‐operative morbidity, Outcome 3 Recombinant VIIa (rFVIIa) low dose (20 to 50 mcg/kg) versus control.
Figuras y tablas -
Analysis 2.3

Comparison 2 Peri‐operative morbidity, Outcome 3 Recombinant VIIa (rFVIIa) low dose (20 to 50 mcg/kg) versus control.

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Comparison 2 Peri‐operative morbidity, Outcome 4 Recombinant VIIa (rFVIIa) high dose (80 to 100 mcg/kg) versus low dose (20 to 50 mcg/kg).
Figuras y tablas -
Analysis 2.4

Comparison 2 Peri‐operative morbidity, Outcome 4 Recombinant VIIa (rFVIIa) high dose (80 to 100 mcg/kg) versus low dose (20 to 50 mcg/kg).

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Study

Antithrombin

Control

P value

Infected intra‐abdominal collection

Shimada 1994

1/13 (7.7%)

1/11 (9.1%)

P > 0.9999

Figuras y tablas -
Analysis 2.5

Comparison 2 Peri‐operative morbidity, Outcome 5 Anitithrombin III versus control.

Ir a la figura de la revisión
Comparison 1. Intervention versus control

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality Show forest plot

4

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1 Aprotinin versus control

1

37

Risk Ratio (M‐H, Fixed, 95% CI)

1.18 [0.18, 7.48]

1.2 Tranexamic acid versus control

1

217

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.3 Recombinant VIIa (rFVIIa) high dose (80 to 100 mcg/kg) versus control

2

272

Risk Ratio (M‐H, Fixed, 95% CI)

0.79 [0.18, 3.51]

1.4 Recombinant VIIa (rFVIIa) low dose (20 to 50 mcg/kg) versus control

2

273

Risk Ratio (M‐H, Fixed, 95% CI)

1.59 [0.43, 5.89]

1.5 Recombinant VIIa (rFVIIa) high dose (80 to 100 mcg/kg) versus low dose (20 to 50 mcg/kg)

2

267

Risk Ratio (M‐H, Fixed, 95% CI)

0.46 [0.10, 2.08]

2 Survival Show forest plot

Other data

No numeric data

2.1 Aprotinin versus control

Other data

No numeric data

3 Liver failure Show forest plot

Other data

No numeric data

3.1 Antithrombin III versus control

Other data

No numeric data

4 Peri‐operative morbidity

Other data

No numeric data

4.1 See analysis 2

Other data

No numeric data

5 Number requiring allogeneic blood transfusion Show forest plot

5

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

5.1 Aprotinin versus control

1

97

Risk Ratio (M‐H, Fixed, 95% CI)

0.43 [0.21, 0.89]

5.2 Tranexamic acid versus control

1

214

Risk Ratio (M‐H, Fixed, 95% CI)

0.03 [0.00, 0.46]

5.3 Desmopressin versus control

1

59

Risk Ratio (M‐H, Fixed, 95% CI)

0.58 [0.15, 2.21]

5.4 Recombinant VIIa (rFVIIa) high dose (80 to 100 mcg/kg) versus control

2

272

Risk Ratio (M‐H, Fixed, 95% CI)

0.86 [0.62, 1.20]

5.5 Recombinant VIIa (rFVIIa) low dose (20 to 50 mcg/kg) versus control

2

273

Risk Ratio (M‐H, Fixed, 95% CI)

1.24 [0.94, 1.64]

5.6 Recombinant VIIa (rFVIIa) high dose (80 to 100 mcg/kg) versus low dose (20 to 50 mcg/kg)

2

267

Risk Ratio (M‐H, Fixed, 95% CI)

0.69 [0.51, 0.94]

6 Red cell transfusion Show forest plot

4

Std. Mean Difference (IV, Fixed, 95% CI)

Subtotals only

6.1 Desmopressin versus control

1

59

Std. Mean Difference (IV, Fixed, 95% CI)

‐0.31 [‐0.82, 0.21]

6.2 Recombinant VIIa (rFVIIa) high dose (80 to 100 mcg/kg) versus control

2

272

Std. Mean Difference (IV, Fixed, 95% CI)

0.01 [‐0.23, 0.24]

6.3 Recombinant VIIa (rFVIIa) high dose (20 to 50 mcg/kg) versus control

2

269

Std. Mean Difference (IV, Fixed, 95% CI)

0.19 [‐0.05, 0.43]

6.4 Recombinant VIIa (rFVIIa) high dose (80 to 100 mcg/kg) versus low dose (20 to 50 mcg/kg)

2

267

Std. Mean Difference (IV, Fixed, 95% CI)

‐0.19 [‐0.43, 0.05]

6.5 Antithrombin versus control

1

24

Std. Mean Difference (IV, Fixed, 95% CI)

0.07 [‐0.73, 0.88]

7 Operating time (minutes) Show forest plot

6

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

7.1 Aprotinin versus control

1

97

Mean Difference (IV, Fixed, 95% CI)

‐1.0 [‐30.08, 28.08]

7.2 Tranexamic acid versus control

1

214

Mean Difference (IV, Fixed, 95% CI)

‐52.20 [‐86.15, ‐18.25]

7.3 Desmopressin versus control

1

59

Mean Difference (IV, Fixed, 95% CI)

‐30.0 [‐112.69, 52.69]

7.4 Recombinant VIIa (rFVIIa) high dose (80 to 100 mcg/kg) versus control

2

272

Mean Difference (IV, Fixed, 95% CI)

‐16.80 [‐40.42, 6.81]

7.5 Recombinant VIIa (rFVIIa) high dose (20 to 50 mcg/kg) versus control

2

269

Mean Difference (IV, Fixed, 95% CI)

7.38 [‐18.41, 33.16]

7.6 Recombinant VIIa (rFVIIa) high dose (80 to 100 mcg/kg) versus low dose (20 to 50 mcg/kg)

2

267

Mean Difference (IV, Fixed, 95% CI)

‐24.29 [‐48.84, 0.27]

7.7 Antithrombin versus control

1

24

Mean Difference (IV, Fixed, 95% CI)

‐28.0 [‐79.80, 23.80]

8 Hospital stay (days) Show forest plot

Other data

No numeric data

8.1 Tranexamic acid versus control

Other data

No numeric data

9 Transection blood loss (ml) Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

9.1 Tranexamic acid versus control

1

214

Mean Difference (IV, Fixed, 95% CI)

‐260.0 [‐434.99, ‐85.01]

9.2 Desmopressin versus control

1

59

Mean Difference (IV, Fixed, 95% CI)

‐45.0 [‐626.86, 536.86]

10 Operative blood loss (ml) Show forest plot

6

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

10.1 Aprotinin versus control

1

97

Mean Difference (IV, Fixed, 95% CI)

‐434.00 [‐873.67, 1.67]

10.2 Tranexamic acid versus control

1

214

Mean Difference (IV, Fixed, 95% CI)

‐300.0 [‐502.05, ‐97.95]

10.3 Desmopressin versus control

1

59

Mean Difference (IV, Fixed, 95% CI)

32.5 [‐695.69, 760.69]

10.4 Recombinant VIIa (rFVIIa) high dose (80 to 100 mcg/kg) versus control

2

272

Mean Difference (IV, Fixed, 95% CI)

‐156.86 [‐427.71, 113.99]

10.5 Recombinant VIIa (rFVIIa) low dose (20 to 50 mcg/kg) versus control

2

273

Mean Difference (IV, Fixed, 95% CI)

138.29 [‐166.99, 443.57]

10.6 Recombinant VIIa (rFVIIa) high dose (80 to 100 mcg/kg) versus low dose (20 to 50 mcg/kg)

2

267

Mean Difference (IV, Fixed, 95% CI)

‐299.54 [‐577.54, ‐21.54]

10.7 Antithrombin versus control

1

24

Mean Difference (IV, Fixed, 95% CI)

463.00 [‐326.67, 1252.67]

11 Bilirubin (micromol/litre) Show forest plot

Other data

No numeric data

11.1 Antithrombin III versus control

Other data

No numeric data

12 Prothrombin activity (percentage of normal activity) Show forest plot

Other data

No numeric data

12.1 Aprotinin versus control

Other data

No numeric data

13 Aspartate transaminase (international units per litre) (peak) Show forest plot

Other data

No numeric data

13.1 Antithrombin III versus control

Other data

No numeric data

14 Alanine transminase (international units per litre) (peak) Show forest plot

Other data

No numeric data

14.2 Antithrombin III versus control

Other data

No numeric data
Figuras y tablas -
Comparison 1. Intervention versus control
Ir a la tabla de la revisión
Comparison 2. Peri‐operative morbidity

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Tranexamic acid versus control Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1 Ascites

1

214

Risk Ratio (M‐H, Fixed, 95% CI)

0.98 [0.29, 3.29]

1.2 Intra‐abdominal abscess

1

214

Risk Ratio (M‐H, Fixed, 95% CI)

0.74 [0.26, 2.05]

1.3 Bile leak

1

214

Risk Ratio (M‐H, Fixed, 95% CI)

1.96 [0.37, 10.49]

1.4 Wound infection

1

214

Risk Ratio (M‐H, Fixed, 95% CI)

0.65 [0.11, 3.84]

1.5 Pleural effusion

1

214

Risk Ratio (M‐H, Fixed, 95% CI)

0.49 [0.05, 5.33]

2 Recombinant VIIa (rFVIIa) high dose (80 to 100 mcg/kg) versus control Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2.1 Bile leak

1

150

Risk Ratio (M‐H, Fixed, 95% CI)

0.34 [0.01, 8.27]

2.2 Hyperamylasemia

1

150

Risk Ratio (M‐H, Fixed, 95% CI)

3.08 [0.13, 74.42]

2.3 Pleural effusion

1

150

Risk Ratio (M‐H, Fixed, 95% CI)

3.08 [0.13, 74.42]

2.4 Myocardial infarction

2

272

Risk Ratio (M‐H, Fixed, 95% CI)

3.08 [0.13, 74.42]

2.5 Pulmonary embolism

2

272

Risk Ratio (M‐H, Fixed, 95% CI)

1.05 [0.15, 7.28]

2.6 Deep vein thrombosis

1

122

Risk Ratio (M‐H, Fixed, 95% CI)

1.07 [0.16, 7.34]

2.7 Portal vein thrombosis

2

272

Risk Ratio (M‐H, Fixed, 95% CI)

0.36 [0.01, 8.56]

2.8 Mesenteric vein thrombosis

1

150

Risk Ratio (M‐H, Fixed, 95% CI)

3.08 [0.13, 74.42]

3 Recombinant VIIa (rFVIIa) low dose (20 to 50 mcg/kg) versus control Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

3.1 Bile leak

1

147

Risk Ratio (M‐H, Fixed, 95% CI)

1.07 [0.07, 16.79]

3.2 Hyperamylasemia

1

147

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.3 Pleural effusion

1

147

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.4 Myocardial infarction

2

273

Risk Ratio (M‐H, Fixed, 95% CI)

5.0 [0.24, 102.10]

3.5 Pulmonary embolism

2

273

Risk Ratio (M‐H, Fixed, 95% CI)

1.03 [0.14, 7.38]

3.6 Deep vein thrombosis

1

126

Risk Ratio (M‐H, Fixed, 95% CI)

0.2 [0.01, 4.08]

3.7 Portal vein thrombosis

2

273

Risk Ratio (M‐H, Fixed, 95% CI)

1.03 [0.15, 7.14]

3.8 Mesenteric vein thrombosis

1

147

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4 Recombinant VIIa (rFVIIa) high dose (80 to 100 mcg/kg) versus low dose (20 to 50 mcg/kg) Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

4.1 Bile leak

1

145

Risk Ratio (M‐H, Fixed, 95% CI)

0.32 [0.01, 7.73]

4.2 Hyperamylasemia

1

145

Risk Ratio (M‐H, Fixed, 95% CI)

2.88 [0.12, 69.55]

4.3 Pleural effusion

1

145

Risk Ratio (M‐H, Fixed, 95% CI)

2.88 [0.12, 69.55]

4.4 Myocardial infarction

2

267

Risk Ratio (M‐H, Fixed, 95% CI)

0.68 [0.11, 4.12]

4.5 Pulmonary embolism

2

267

Risk Ratio (M‐H, Fixed, 95% CI)

1.07 [0.07, 16.69]

4.6 Deep vein thrombosis

1

122

Risk Ratio (M‐H, Fixed, 95% CI)

5.33 [0.26, 108.84]

4.7 Portal vein thrombosis

2

267

Risk Ratio (M‐H, Fixed, 95% CI)

0.32 [0.01, 7.73]

4.8 Mesenteric vein thrombosis

1

145

Risk Ratio (M‐H, Fixed, 95% CI)

2.88 [0.12, 69.55]

5 Anitithrombin III versus control Show forest plot

Other data

No numeric data

5.1 Infected intra‐abdominal collection

Other data

No numeric data
Figuras y tablas -
Comparison 2. Peri‐operative morbidity
Ir a la tabla de la revisión