Clinical Impact of Red Cell Storage Age

Study Overview
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Brief Summary
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The recent four RCTs evaluating effects of RBC storage age on morbidity and mortality found no statistically significant adverse effects of longer stored RBC compared to shorter storage ages. Unfortunately, none of these RCTs had sufficient numbers of subjects receiving RBC at either storage age extreme to identify consequences of RBC transfusion at these limits. To better investigate effects of RBC storage age on clinical outcomes, this study will perform secondary meta-analyses of merged common patient data elements -individual patient data (IPD) meta-analysis (IPDMA) - from the nearly 33,000 subjects enrolled in the four RCTs.

Official Title
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Clinical Impact of Red Cell Storage Age: Individual Patient Data Meta-Analysis of Four Recent Large Randomized Trials

Conditions
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RBC Transfusions

Intervention / Treatment
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* Other: no intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Received at least one RBC transfusion >=18 years of age Exclusion Criteria: N/A

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Reference group<br>Transfused RBC stored 8-35 days | Other: no intervention<br>* This is an observational retrospective study (meta-analysis)<br>|
| less than or equal 7 days<br>Transfused RBC stored =<7 days | Other: no intervention<br>* This is an observational retrospective study (meta-analysis)<br>|
| more than 7 days<br>Transfused RBC stored <7 days | Other: no intervention<br>* This is an observational retrospective study (meta-analysis)<br>|
| less that or equal 10 days<br>Transfused RBC stored =<10 days | Other: no intervention<br>* This is an observational retrospective study (meta-analysis)<br>|
| more that 10 days<br>Transfused RBC stored >10 days | Other: no intervention<br>* This is an observational retrospective study (meta-analysis)<br>|
| more than 35 days<br>Transfused RBC stored >35 days | Other: no intervention<br>* This is an observational retrospective study (meta-analysis)<br>|
| less than or equal 35 days<br>Transfused RBC stored =<35 days | Other: no intervention<br>* This is an observational retrospective study (meta-analysis)<br>|
| less than 18 days<br>Transfused RBC stored <18 days | Other: no intervention<br>* This is an observational retrospective study (meta-analysis)<br>|
| more than or equal 18 days<br>Transfused RBC stored =>18 days | Other: no intervention<br>* This is an observational retrospective study (meta-analysis)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Estimate the effect of transfused RBC storage-age on time to all-cause mortality | 28 days after transfusion | 
| Hospital length of stay | Estimate the effect of transfused RBC storage-age on hospital stay | after transfusion through 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality at 28 days for long-storage | all-cause mortality at 28 days comparing subjects who received (one or more) RBC unit ≥ 35 days vs. no unit > 35 days | 28 days after transfusion | 
| 28 day mortality for short-storage | 28 day mortality for subjects who received (one or more) RBC unit ≤ 7 days vs. no unit ≤ 7 days | 28 days after transfusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RBC transfusions, storage age, meta-analysis