Leukoreduction for the prevention of adverse reactions from allogeneic blood transfusion

Daniel Simancas‐Racines; Dimelza Osorio; Arturo J Martí‐Carvajal; Ingrid Arevalo‐Rodriguez

doi:10.1002/14651858.CD009745.pub2

Cochrane Database of Systematic Reviews

Leucorreducción para la prevención de las reacciones adversas de la transfusión de sangre alogénica

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DOI:

https://doi.org/10.1002/14651858.CD009745.pub2 Copiar DOI

Base de datos:

Cochrane Database of Systematic Reviews

Versión publicada:

03 diciembre 2015see what's new

Tipo:

Intervention

Etapa:

Review

Grupo Editorial Cochrane:

Grupo Cochrane de Lesiones

Copyright:

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

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Autores

Daniel Simancas‐Racines

Correspondencia a: Facultad de Ciencias de la Salud Eugenio Espejo, Universidad Tecnológica Equinoccial, Quito, Ecuador

[email protected]

[email protected]
Dimelza Osorio

Facultad de Ciencias de la Salud Eugenio Espejo, Universidad Tecnológica Equinoccial, Quito, Ecuador
Arturo J Martí‐Carvajal

Iberoamerican Cochrane Network, Valencia, Venezuela
Ingrid Arevalo‐Rodriguez

Division of Research, Fundación Universitaria de Ciencias de la Salud ‐ Hospital de San José/Hospital Infantil de San José, Bogotá D.C., Colombia

Contributions of authors

All review authors contributed to the conception and design of this Cochrane review. Doctors Simancas‐Racines, Arevalo‐Rodriguez and Osorio contributed to the analysis and interpretation of data, and drafted the manuscript. All review authors contributed by commenting on the review critically for intellectual content and gave final approval of the document to be published.

Sources of support

Internal sources

Universidad Tecnológica Equinoccial, Ecuador.

Academic
Fundación Universitaria de Ciencias de la Salud, Bogotá D.C., Colombia.

External sources

Iberoamerican Cochrane Center, Spain.

Academic

Declarations of interest

IA‐R: None known.

AM‐C: None known.

DO: None known.

DS‐R: None known.

Acknowledgements

Daniel Simancas‐Racines is a Ph.D. candidate at the Department of Pediatrics, Gynecology and Obstetrics, and Preventive Medicine, Universitat Autònoma de Barcelona, Spain.

We thank Ms. Marta Roqué i Figuls, Iberoamerican Cochrane Centre, for her advice on statistical analysis; Dr. Christian Gluud, Centre for Clinical Intervention Research, Denmark, for his advice on interpreting the trial sequential analyses; and Ms. Maria Victoria Leo Rosas for revising and improving the grammar and style of the review.

This project was supported by the UK National Institute for Health Research, through Cochrane Infrastructure funding to the Cochrane Injuries Group. The views and opinions expressed are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or the Department of Health.

Version history

Published

Title

Stage

Authors

Version

2015 Dec 03

Leukoreduction for the prevention of adverse reactions from allogeneic blood transfusion

Review

Daniel Simancas‐Racines, Dimelza Osorio, Arturo J Martí‐Carvajal, Ingrid Arevalo‐Rodriguez

https://doi.org/10.1002/14651858.CD009745.pub2

2012 Mar 14

Leukoreduction for the prevention of adverse reactions from allogeneic blood transfusion

Protocol

Daniel Simancas‐Racines, Arturo J Martí‐Carvajal, Ricardo Hidalgo, Shrikant Bangdiwala

https://doi.org/10.1002/14651858.CD009745

Differences between protocol and review

In order to improve the quality of this Cochrane review, we made the following changes from the original protocol (Simancas‐Racines 2012):

Data synthesis included a second meta‐analysis: 'only transfused patients' as a sensitivity analysis. We performed this analysis due to the important number of patients not transfused as reported in most of the included studies. This analysis complements the main analysis planned in the review protocol: events reported among the total number of randomised patients.
We carried out a sensitivity analysis "excluding post‐storage leukoreduction studies" to explore the effect of this variable on the effect estimate.
We conducted a TSA to assess the risk of random errors in the cumulative meta‐analyses.
We changed our criteria for assessing the statistical heterogeneity in the meta‐analyses. In the protocol it was classified an I² statistic value of 40 to 60% as moderate, and 75% and above as high. In the review, we have now defined moderate heterogeneity as an I² statistic of 50 to 74%, and high as 75% or above.

Notes

In future versions of this review we will also include, for all outcomes:

a subgroup analysis by medical condition
a subgroup analysis by type of filter
a sensitivity analysis by buffy coat

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Adolescent; Adult; Female; Humans; Male;

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.

Figure 1

Study flow diagram.

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Figure 2

'Risk of bias' graph: review authors' judgements about each 'Risk of bias' item presented as percentages across all included studies.

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Figure 3

'Risk of bias' summary: review authors' judgements about each 'Risk of bias' item for each included study.

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Figure 4

TSA calculated to reliably detect a 25% relative change in the incidence of death from any cause, assuming a control group event rate of 9.34% with a power of 80% at an alpha of 5%

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Figure 5

Funnel plot of comparison: 1 Leukoreduced PRBC versus non‐leukoreduced PRBC. Main Analysis (Randomised patients), outcome: 1.3 Infection. Number of events of the total of randomised patients reported.

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Figure 6

TSA calculated to reliably detect a 25% relative change in the incidence of infection from any cause, assuming a control group event rate of 20.4% with a power of 80% at an alpha of 5%.

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Figure 7

TSA calculated to reliably detect a 25% relative change in the incidence of fever, assuming a control group event rate of 38.7% with a power of 80% at an alpha of 5%.

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Analysis 1.1

Comparison 1 Leukoreduced PRBC versus non‐leukoreduced PRBC. Main analysis (randomised patients), Outcome 1 TRALI. Number of events of the total of randomised patients reported.

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Analysis 1.2

Comparison 1 Leukoreduced PRBC versus non‐leukoreduced PRBC. Main analysis (randomised patients), Outcome 2 Death. Number of events of the total of randomised patients reported.

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Analysis 1.3

Comparison 1 Leukoreduced PRBC versus non‐leukoreduced PRBC. Main analysis (randomised patients), Outcome 3 Infection. Number of events of the total of randomised patients reported.

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Analysis 1.4

Comparison 1 Leukoreduced PRBC versus non‐leukoreduced PRBC. Main analysis (randomised patients), Outcome 4 Adverse events. Number of events of the total of randomised patients reported.

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Analysis 2.1

Comparison 2 Leukoreduced PRBC versus non‐leukoreduced PRBC. Secondary analysis (transfused patients), Outcome 1 TRALI. Number of events of the total of transfused patients reported.

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Analysis 2.2

Comparison 2 Leukoreduced PRBC versus non‐leukoreduced PRBC. Secondary analysis (transfused patients), Outcome 2 Death. Number of events of the total of transfused patients reported.

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Analysis 2.3

Comparison 2 Leukoreduced PRBC versus non‐leukoreduced PRBC. Secondary analysis (transfused patients), Outcome 3 Infection. Number of events of the total of transfused patients reported.

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Analysis 2.4

Comparison 2 Leukoreduced PRBC versus non‐leukoreduced PRBC. Secondary analysis (transfused patients), Outcome 4 Adverse events. Number of events of the total of transfused patients reported.

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Summary of findings for the main comparison. Leukoreduced PRBCs versus non‐leukoreduced PRBCs for preventing adverse reaction from allogeneic blood transfusion

Leukoreduced PRBCs versus non‐leukoreduced PRBCs for preventing adverse reaction from allogeneic blood transfusion
Patient or population: Patients receiving RBC transfusion Settings: Any Intervention: Leukoreduced PRBCs Comparison: Non‐leukoreduced PRBCs
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	Number of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Non‐leukoreduced packed RBCs	Leukoreduced packed RBCs
TRALI Follow‐up: mean 28 days	Study population		RR 0.96 (0.67 to 1.36)	1864 (1 study)	⊕⊕⊝⊝ low¹	TSA yielded an inconclusive result.
	63 per 1000	61 per 1000 (42 to 86)
Death due to any cause Follow‐up: median 2.5 months	Study population		RR 0.81 (0.58 to 1.12)	6485 (9 studies)	⊕⊝⊝⊝ very low²	TSA yielded an inconclusive result.
	93 per 1000	76 per 1000 (54 to 104)
Infection from any cause Follow‐up: mean 2.5 months	Study population		RR 0.80 (0.62 to 1.03)	6709 (10 studies)	⊕⊝⊝⊝ very low³	TSA yielded an inconclusive result.
	204 per 1000	163 per 1000 (127 to 210)
Adverse events Follow‐up: mean 3 months	Study population		RR 0.81 (0.64 to 1.02)	634 (2 studies)	⊕⊕⊝⊝ low⁴	TSA yielded an inconclusive result.
	387 per 1000	314 per 1000 (248 to 395)
Non‐infectious complication	Study population		Not estimable	—	—	No trial assessed this outcome.
	Not estimable	Not estimable
The basis for the assumed risk* was the median control group risk across studies. The corresponding risk (and its 95% CI) 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; TRALI: Transfusion‐related acute lung injury; RBC: Red blood cell; PRBC: Packed red blood cell; DARIS: Diversity‐adjusted required information size.
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹Downgraded by two due to imprecision: small sample size as compared with the calculated DARIS and the wide CI overlapping zones of no effect, as well as potential harm or benefit, or both. Few events reported. ²Downgraded due to: high risk of bias (Six of nine included studies have high or unclear risk of bias. ‐1); important heterogeneity (I² statistic: 63%, ‐1); and imprecision as reflected in the wide CI and an insufficient accrued information size compared with the DARIS (‐1). ³Downgraded due to: high risk of bias (Seven of 10 included studies were at high or unclear risk of bias, ‐1); important heterogeneity (I² statistic: 84%, ‐2); and imprecision due to the CI crossing the threshold of meaningful effect and an insufficient sample size as compared with the DARIS (‐1) ⁴Downgraded due to: high risk of bias (All included studies evaluated were at high risk of bias, ‐1) and imprecision due to the CI crossing the threshold of meaningful effect and an insufficient sample size as compared with the DARIS (‐1).

Summary of findings for the main comparison. Leukoreduced PRBCs versus non‐leukoreduced PRBCs for preventing adverse reaction from allogeneic blood transfusion

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Comparison 1. Leukoreduced PRBC versus non‐leukoreduced PRBC. Main analysis (randomised patients)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 TRALI. Number of events of the total of randomised patients reported Show forest plot	1	1864	Risk Ratio (M‐H, Random, 95% CI)	0.96 [0.67, 1.36]

2 Death. Number of events of the total of randomised patients reported Show forest plot	9	6485	Risk Ratio (M‐H, Random, 95% CI)	0.81 [0.58, 1.12]

3 Infection. Number of events of the total of randomised patients reported Show forest plot	10	6709	Risk Ratio (M‐H, Random, 95% CI)	0.80 [0.62, 1.03]

4 Adverse events. Number of events of the total of randomised patients reported Show forest plot	2	634	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.64, 1.02]

4.1 Fever	2	634	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.64, 1.02]

Comparison 1. Leukoreduced PRBC versus non‐leukoreduced PRBC. Main analysis (randomised patients)

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Comparison 2. Leukoreduced PRBC versus non‐leukoreduced PRBC. Secondary analysis (transfused patients)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 TRALI. Number of events of the total of transfused patients reported Show forest plot	1	268	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.74, 1.29]

2 Death. Number of events of the total of transfused patients reported Show forest plot	10	4060	Risk Ratio (M‐H, Random, 95% CI)	0.80 [0.60, 1.07]

3 Infection. Number of events of the total of transfused patients reported Show forest plot	10	3557	Risk Ratio (M‐H, Random, 95% CI)	0.76 [0.58, 1.00]

4 Adverse events. Number of events of the total of transfused patients reported Show forest plot	2	544	Risk Ratio (M‐H, Fixed, 95% CI)	0.75 [0.60, 0.94]

4.1 Fever	2	544	Risk Ratio (M‐H, Fixed, 95% CI)	0.75 [0.60, 0.94]

Comparison 2. Leukoreduced PRBC versus non‐leukoreduced PRBC. Secondary analysis (transfused patients)

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Leucorreducción para la prevención de las reacciones adversas de la transfusión de sangre alogénica

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