Clinical Impact of Red Cell Storage Age
- Conditions
- RBC Transfusions
- Interventions
- Other: no intervention
- Registration Number
- NCT05482737
- Lead Sponsor
- University of Minnesota
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33000
- Received at least one RBC transfusion
- >=18 years of age
- N/A
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description less than or equal 7 days no intervention Transfused RBC stored =\<7 days less than 18 days no intervention Transfused RBC stored \<18 days more than 7 days no intervention Transfused RBC stored \<7 days more than 35 days no intervention Transfused RBC stored \>35 days Reference group no intervention Transfused RBC stored 8-35 days more that 10 days no intervention Transfused RBC stored \>10 days less than or equal 35 days no intervention Transfused RBC stored =\<35 days less that or equal 10 days no intervention Transfused RBC stored =\<10 days more than or equal 18 days no intervention Transfused RBC stored =\>18 days
- Primary Outcome Measures
Name Time Method All-cause mortality 28 days after transfusion Estimate the effect of transfused RBC storage-age on time to all-cause mortality
Hospital length of stay after transfusion through 28 days Estimate the effect of transfused RBC storage-age on hospital stay
- Secondary Outcome Measures
Name Time Method All-cause mortality at 28 days for long-storage 28 days after transfusion all-cause mortality at 28 days comparing subjects who received (one or more) RBC unit ≥ 35 days vs. no unit \> 35 days
28 day mortality for short-storage 28 days after transfusion 28 day mortality for subjects who received (one or more) RBC unit ≤ 7 days vs. no unit ≤ 7 days
Trial Locations
- Locations (1)
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States