Clinical Impact of Red Cell Storage Age
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Reference group Transfused RBC stored 8-35 days |
Other: no intervention
This is an observational retrospective study (meta-analysis)
|
| less than or equal 7 days Transfused RBC stored =<7 days |
Other: no intervention
This is an observational retrospective study (meta-analysis)
|
| more than 7 days Transfused RBC stored <7 days |
Other: no intervention
This is an observational retrospective study (meta-analysis)
|
| less that or equal 10 days Transfused RBC stored =<10 days |
Other: no intervention
This is an observational retrospective study (meta-analysis)
|
| more that 10 days Transfused RBC stored >10 days |
Other: no intervention
This is an observational retrospective study (meta-analysis)
|
| more than 35 days Transfused RBC stored >35 days |
Other: no intervention
This is an observational retrospective study (meta-analysis)
|
| less than or equal 35 days Transfused RBC stored =<35 days |
Other: no intervention
This is an observational retrospective study (meta-analysis)
|
| less than 18 days Transfused RBC stored <18 days |
Other: no intervention
This is an observational retrospective study (meta-analysis)
|
| more than or equal 18 days Transfused RBC stored =>18 days |
Other: no intervention
This is an observational retrospective study (meta-analysis)
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Received at least one RBC transfusion
-
=18 years of age
Exclusion Criteria:
- N/A
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
Sponsors and Collaborators
- University of Minnesota
Investigators
- Principal Investigator: Marie Steiner, MD, University of Minnesota
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pending 4