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OpenTrials
Completed

NCT Number: NCT05482737

Clinical Impact of Red Cell Storage Age

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.

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Key information

Conditions

RBC Transfusions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • N/A

Treatment and study plan

No intervention

Other

This is an observational retrospective study (meta-analysis)

Primary outcomes

  1. All-cause mortality

    Time frame: 28 days after transfusion

    Estimate the effect of transfused RBC storage-age on time to all-cause mortality

  2. Hospital length of stay

    Time frame: after transfusion through 28 days

    Estimate the effect of transfused RBC storage-age on hospital stay

Secondary outcomes

  1. All-cause mortality at 28 days for long-storage

    Time frame: 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

  2. 28 day mortality for short-storage

    Time frame: 28 days after transfusion

    28 day mortality for subjects who received (one or more) RBC unit ≤ 7 days vs. no unit ≤ 7 days

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Aug 1, 2022
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.