Sex-mismatched red blood cell transfusions and mortality: A systematic review and meta-analysis.
Michelle P Zeller, Bram Rochwerg, Erin Jamula...
https://pubmed.ncbi.nlm.nih.gov/31124172/Actively Recruiting
Led by Michelle Zeller · Updated on 2026-03-12
11082
Participants Needed
8
Research Sites
12 weeks
Total Duration
Researchers are investigating whether matching the sex of blood donors and recipients for red blood cell RBC transfusions can improve patient outcomes in critically ill adults admitted to intensive care units ICUs. This randomized controlled trial will compare mortality rates between patients receiving sex-matched RBC transfusions and those receiving sex-mismatched RBC transfusions. Previous studies and biological evidence suggest that sex-matched transplants may benefit patients, but current transfusion practices do not consider donor-recipient sex. The study will enroll adult ICU patients requiring RBC transfusions and randomly assign them to receive either sex-matched or sex-mismatched blood. The trial will take place across multiple Canadian sites and include two groups one receiving sex-matched RBC transfusions and the other sex-mismatched transfusions. The primary outcome is 30-day mortality, with secondary outcomes including in-hospital mortality, 90-day mortality, time to death, changes in hemoglobin and kidney function, ICU and hospital stay length, transfusion reactions, and cost-effectiveness. Participants will be monitored from the time of randomization through 30 to 90 days post-transfusion, with assessments including blood tests to measure hemoglobin and creatinine levels, tracking of transfusion products used, and recording of adverse reactions. Researchers will collect data on patient outcomes, transfusion details, and healthcare resource use. The study aims to provide evidence on whether sex-matched transfusions improve survival and inform future blood transfusion practices and blood inventory management.
CONDITIONS
Effects of Donor-recipient Sex-matched Blood Transfusion on Patient Outcomes
M
Michelle Zeller, Doctor of Medicine
B
Bambie Levoy-Jones, Honours Bachelor of Science
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Michelle Zeller
Lead Sponsor
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of ICU admission requiring transfusion, up to 90 days post-randomization
Participants receive red blood cell transfusions that are either sex-matched or sex-mismatched based on randomization while admitted to the ICU.
Visits occur as part of ICU care during transfusion period
Duration - Up to 90 days post-randomization
Participants are monitored for outcomes including mortality, hemoglobin and creatinine levels, transfusion reactions, and length of ICU and hospital stay after transfusion.
Visits aligned with routine ICU and hospital care up to 90 days
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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Lead Sponsor
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor