Clinical Impact of Red Cell Storage Age
1 other identifier
observational
33,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2019
CompletedFirst Submitted
Initial submission to the registry
July 27, 2022
CompletedFirst Posted
Study publicly available on registry
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2024
CompletedOctober 3, 2024
October 1, 2024
4.1 years
July 27, 2022
October 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
All-cause mortality at 28 days for long-storage
28 days after transfusion
28 day mortality for short-storage
28 days after transfusion
Study Arms (9)
Reference group
Transfused RBC stored 8-35 days
less than or equal 7 days
Transfused RBC stored =\<7 days
more than 7 days
Transfused RBC stored \<7 days
less that or equal 10 days
Transfused RBC stored =\<10 days
more that 10 days
Transfused RBC stored \>10 days
more than 35 days
Transfused RBC stored \>35 days
less than or equal 35 days
Transfused RBC stored =\<35 days
less than 18 days
Transfused RBC stored \<18 days
more than or equal 18 days
Transfused RBC stored =\>18 days
Interventions
This is an observational retrospective study (meta-analysis)
Eligibility Criteria
Subjects in the recent four RCTs who are 18 years or older and have received at least one RBC transfusion.
You may qualify if:
- Received at least one RBC transfusion
- \>=18 years of age
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Marie Steiner, MD
University of Minnesota
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2022
First Posted
August 1, 2022
Study Start
July 1, 2019
Primary Completion
August 1, 2023
Study Completion
August 30, 2024
Last Updated
October 3, 2024
Record last verified: 2024-10