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Tratamiento antifibrinolítico para la prevención de la hemorragia oral en pacientes con hemofilia o enfermedad de Von Willebrand sometidos a una intervención quirúrgica oral menor o extracciones dentales

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ver la versión actual 19 abril 2019

Información

DOI:
https://doi.org/10.1002/14651858.CD011385.pub2Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 24 diciembre 2015see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:

  1. Grupo Cochrane de Fibrosis quística y enfermedades genéticas

Copyright:
  1. Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Contraer

Autores

  • Karin PM van Galen

    Correspondencia a: Van Creveldkliniek / Department of Haematology, University Medical Centre Utrecht, Utrecht, Netherlands

    [email protected]

    [email protected]

  • Eveline T Engelen

    University Medical Centre Utrecht, Utrecht, Netherlands

  • Evelien P Mauser‐Bunschoten

    Van Creveldkliniek / Department of Haematology, University Medical Centre Utrecht, Utrecht, Netherlands

  • Robert JJ van Es

    Oral and Maxillofacial Surgery, University Medical Center Utrecht, Utrecht, Netherlands

  • Roger EG Schutgens

    Van Creveldkliniek / Department of Haematology, University Medical Centre Utrecht, Utrecht, Netherlands

Contributions of authors

KPM van Galen: guarantor of the review, conceiving, designing, coordinating and writing of the review, data collection, extraction and critical appraisal. Screening of search results and of retrieved papers against eligibility criteria. Data analysis and interpretation.

ET Engelen: designing search strategies and undertaking searches. Screening of search results and of retrieved papers against eligibility criteria. Data collection, extraction, writing of the review and critical appraisal.

RJJ van Es: interpretation of data, providing a clinical perspective and general advice on the review.

EP Mauser‐Bunschoten: interpretation of data, providing a methodological, clinical, consumer and policy perspective.

REG Schutgens: supervising of the review, securing funding. Verifing the data extraction of trials identified for inclusion.

Sources of support

Internal sources

  • No sources of support supplied

External sources

  • National Institute for Health Research, UK.

    This systematic review was supported by the National Institute for Health Research, via Cochrane Infrastructure funding to the Cochrane Cystic Fibrosis and Genetic Disorders Group.

Declarations of interest

Karin PM van Galen: none known.

Eveline T Engelen: none known.

Evelien Mauser‐Bunschoten: in my opinion there will be no conflict of interest. Full disclosure ‐ I have provided expert opinion to Baxter and my institution has received payments from Sanquin, NovoNordisk, Bayer, Baxter, Pfizer, Griffols for lectures I have given. My institution has also received funding in relation to a twinning program in Indonesia and education and cooperation with Indonesian haemophilia centers.

Robert JJ van Es: none known.

Roger EG Schutgens: I have no conflicts of interest to declare. Full disclosure ‐ I have provided consultancy to Bayer on new products for hemophilia and ADVANCE working group on behalf of my institution. My institution has received grants from Novo Nordisk for a project 'Project cartilage damage in hemophilia' and from Bayer for a project 'Triumph trial, immunotherapy in hemophilia'. My institution has also received payment from Biotest and Bayer for lectures I have given at hemophilia conferences.

Acknowledgements

We thank Bianca Kramer (Clinical Librarian), the Dutch Cochrane Center and the Cochrane Cystic Fibrosis and Genetic Disorders Group for their help in starting up and conducting this systematic review.

Version history

Published

Title

Stage

Authors

Version

2019 Apr 19

Antifibrinolytic therapy for preventing oral bleeding in patients with haemophilia or Von Willebrand disease undergoing minor oral surgery or dental extractions

Review

Karin PM van Galen, Eveline T Engelen, Evelien P Mauser‐Bunschoten, Robert JJ van Es, Roger EG Schutgens

https://doi.org/10.1002/14651858.CD011385.pub3

2015 Dec 24

Antifibrinolytic therapy for preventing oral bleeding in patients with haemophilia or Von Willebrand disease undergoing minor oral surgery or dental extractions

Review

Karin PM van Galen, Eveline T Engelen, Evelien P Mauser‐Bunschoten, Robert JJ van Es, Roger EG Schutgens

https://doi.org/10.1002/14651858.CD011385.pub2

2014 Dec 05

Antifibrinolytic therapy for preventing oral bleeding in patients with a hemophilia or Von Willebrand disease undergoing oral or dental procedures

Protocol

Karin PM van Galen, Eveline T Engelen, Evelien P Mauser‐Bunschoten, Robert JJ van Es, Roger EG Schutgens

https://doi.org/10.1002/14651858.CD011385

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Humans;

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Risk of bias summary of the included studies
Figuras y tablas -
Figure 1

Risk of bias summary of the included studies

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Trial flow diagram
Figuras y tablas -
Figure 2

Trial flow diagram

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Comparison 1 Antifibrinolytic therapy versus placebo in hemophilia, Outcome 1 Number of people with postoperative bleedings.
Figuras y tablas -
Analysis 1.1

Comparison 1 Antifibrinolytic therapy versus placebo in hemophilia, Outcome 1 Number of people with postoperative bleedings.

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Comparison 1 Antifibrinolytic therapy versus placebo in hemophilia, Outcome 2 Number of side effects requiring withdrawal.
Figuras y tablas -
Analysis 1.2

Comparison 1 Antifibrinolytic therapy versus placebo in hemophilia, Outcome 2 Number of side effects requiring withdrawal.

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Summary of findings for the main comparison. Summary of findings table

Antifibrinolytic therapy compared with placebo or usual care for preventing oral bleeding in patients with haemophilia or Von Willebrand disease undergoing oral or dental procedures

Patient or population: people with haemophilia or Von Willebrand disease

Settings: hospitals, hemophilia centres

Intervention: tranexamic acid (TXA) or epsilon aminocaproic acid (EACA)

Comparison: placebo or no intervention or usual care with or without placebo

Outcomes

Anticipated absolute effects*

Relative effect
(95% CI)

№ of participants
(studies)

Number needed to treat (NNT)

Quality of the evidence
(GRADE)

Comments

Risk with placebo or usual care

Risk with antifibrinolytic therapy

Postoperative bleedings requiring intervention

Study population

Risk difference:

57
(36 to 76)

59
(2 RCTs)

1.8

⊕⊕⊕⊝
MODERATE 1 2 3

67 per 100

(20 events)

10 per 100

(3 events)

Side effects or other adverse events

Study population

Risk difference:

3.4
(‐32 to 38)

59
(2 RCTs)

0.3

⊕⊕⊝⊝
LOW 2 3

0 events

1 event

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

CI: confidence interval; RR: risk ratio; OR: odds ratio;

GRADE Working Group grades of evidence
High quality: we are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: we are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: we have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1 The magnitude of effect was considered large in this study, therefore the quality of evidence was rated up one level.

2 Small sample sizes and lack of studies

3 Heterogeneity between the included trials regarding the proportion of severe people with haemophilia included, the concomitant standard therapy and fibrinolytic agent treatment regimens used

Figuras y tablas -
Summary of findings for the main comparison. Summary of findings table
Ir a la tabla de la revisión
Table 1. Results of the included studies: primary outcomes

Antifibrinolytic therapy compared with placebo or usual care for preventing oral bleeding in people with haemophilia or Von Willebrand disease undergoing oral or dental procedures

Patient or population: people with haemophilia or Von Willebrand disease

Settings: hospitals, hemophilia centres

Intervention: tranexamic acid (TXA) or epsilon aminocaproic acid (EACA)

Comparison: placebo or no intervention or usual care with or without placebo

Primary outcomes

1. Postoperative bleedings requiring intervention

2. Side effects or other adverse events

Absolute risks % (n/ntotal)

Risk difference (RD)
% (95% CI)

Number needed to treat (NNT)

Absolute risks % (n/ntotal)

Risk difference (RD)

(% (95% CI)

Control

Intervention

Control

Intervention

A.Forbes 1972

79% (11/14)

14% (2/14)

65% (37 ‐ 93)

1.5

0% (0/14)

0% (0/14)

0%

B.Walsh 1971

56% (9/16)

7% (1/15)

49% (21 ‐ 77)

2.0

0% (0/16)

7% (1/15)

7% (‐0.06 ‐ 20)

n: number; CI: confidence interval

Figuras y tablas -
Table 1. Results of the included studies: primary outcomes
Ir a la tabla de la revisión
Table 2. Results of the included studies: combination of results in absolute numbers

Antifibrinolytic therapy compared with placebo or usual care for preventing oral bleeding in people with haemophilia or Von Willebrand disease undergoing oral or dental procedures

Patient or population: people with haemophilia or Von Willebrand disease

Settings: hospitals, hemophilia centres

Intervention: tranexamic acid (TXA) or epsilon aminocaproic acid (EACA)

Comparison: placebo or no intervention or usual care with or without placebo

1. Number of people with postoperative bleeding

2. Side effects or other adverse events

Combined absolute risks % (n/ntotal)

Risk difference (RD) (% (95% CI)

Number needed to treat (NNT)

Combined absolute risks % (n/ntotal)

Risk difference (RD)(% (95% CI)

Number needed to treat (NNT)

Control

Intervention

Control

Intervention

Forbes 1972; Walsh 1971

67% (20/30)

10% (3/29)

56% (36% ‐ 76%)

1.8

0% (0/30)

3.4 (1/29)

3.4 (‐32 ‐ 38)

0.3
Figuras y tablas -
Table 2. Results of the included studies: combination of results in absolute numbers
Ir a la tabla de la revisión
Table 3. Results of the included studies: secondary outcomes

Antifibrinolytic therapy compared with placebo or usual care for preventing oral bleeding in patients with haemophilia or Von Willebrand disease undergoing oral or dental procedures

Patient or population: Patients with haemophilia or Von Willebrand disease

Settings: Hospitals, Hemophilia centres

Intervention: Tranexamic acid (TXA) or epsilon aminocaproic acid (EACA)

Comparison: Placebo or no intervention or usual care with or without placebo

Secondary outcomes

1. (Mean) fall in haemoglobin level from baseline

2. Amount of postoperative blood loss: mean per patient mL (range)

3. Need for and dose of clotting factor concentrates:

Mean number of units IU (range) of replacement therapy per root extracted (A) / per patient (B)

Control

Intervention

Control

Intervention

Control

Intervention

A.Forbes 1972

1.4 g/100mL

0.3 g/100mL

84.1 mL (4‐323)

61.2 mL (1‐749)

617 IU (0‐15800) in eleven participants

30 IU and 65 IU in two participants

B.Walsh 1971

Trial centre 1: 6.3%

Trial centre 2: 6.3%

Trial centre 1: 3.9%

Trial centre 2: 3.7%

NR

NR

Trial centre 1: 2331 IU

Trial centre 2: 1881 IU

Trial centre 1: 145 IU

Trial centre 2: 0 IU

Abbreviations:NR: not reported

Figuras y tablas -
Table 3. Results of the included studies: secondary outcomes
Ir a la tabla de la revisión
Comparison 1. Antifibrinolytic therapy versus placebo in hemophilia

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of people with postoperative bleedings Show forest plot

2

59

Risk Difference (M‐H, Random, 95% CI)

‐0.57 [‐0.76, ‐0.37]

2 Number of side effects requiring withdrawal Show forest plot

2

59

Risk Difference (M‐H, Random, 95% CI)

0.03 [‐0.08, 0.13]
Figuras y tablas -
Comparison 1. Antifibrinolytic therapy versus placebo in hemophilia
Ir a la tabla de la revisión