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Clinical Impact of Red Cell Storage Age

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05482737
Enrollment
33000
Registered
2022-08-01
Start date
2019-07-01
Completion date
2024-08-30
Last updated
2024-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

RBC Transfusions

Keywords

RBC transfusions, storage age, meta-analysis

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.

Interventions

OTHERno intervention

This is an observational retrospective study (meta-analysis)

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Received at least one RBC transfusion * \>=18 years of age

Exclusion criteria

* N/A

Design outcomes

Primary

MeasureTime frameDescription
All-cause mortality28 days after transfusionEstimate the effect of transfused RBC storage-age on time to all-cause mortality
Hospital length of stayafter transfusion through 28 daysEstimate the effect of transfused RBC storage-age on hospital stay

Secondary

MeasureTime frameDescription
All-cause mortality at 28 days for long-storage28 days after transfusionall-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-storage28 days after transfusion28 day mortality for subjects who received (one or more) RBC unit ≤ 7 days vs. no unit ≤ 7 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026