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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: RBC Transfusions
• Intervention / Treatment: Other: no intervention

• Study Type: Observational
• Enrollment (Actual): 33000

Contacts and Locations

• Study Contact: Name: Marie Steiner, MD; Phone Number: 6126262778; Email: stein083@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Subjects in the recent four RCTs who are 18 years or older and have received at least one RBC transfusion.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

Number of groups / cohorts

9

Cohorts and Interventions

Group / Cohort	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality at 28 days for long-storage	all-cause mortality at 28 days comparing subjects who received (one or more) RBC unit ≥ 35 days vs. no unit > 35 days	28 days after transfusion
28 day mortality for short-storage	28 day mortality for subjects who received (one or more) RBC unit ≤ 7 days vs. no unit ≤ 7 days	28 days after transfusion

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Marie Steiner, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): August 1, 2023
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: July 27, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: October 1, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: meta-analysis; RBC transfusions; storage age
• Other Study ID Numbers: Pending 4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No