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

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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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