The Effect of Sex-Mismatched Red Blood Cell Transfusion on Endothelial Cell Activation in Critically Ill Patients.
Abdulrahman Alshalani, Lisa van Manen, Margit Boshuizen...
https://pubmed.ncbi.nlm.nih.gov/35611381Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID06840756
Effects of Donor-recipient Sex-matched Versus Sex-mismatched Red Blood Cell Transfusion on Outcomes in Critically Ill Adult Patients
Led by Michelle Zeller · Updated on 2026-03-12
11082
Participants Needed
8
Research Sites
12 weeks
Total Duration
On this page
Sponsors
M
Michelle Zeller
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Brief Title
Effects of Donor-recipient Sex-matched Blood Transfusion on Patient Outcomes
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults (age 18 or older)
- Admission to a participating intensive care unit (ICU)
- Requiring red blood cell (RBC) transfusion
You will not qualify if you...
- Need for a specialized RBC product or unit not readily available (e.g., rare blood type, washed RBCs, complex antibodies)
- Massively bleeding patient (4 or more units ordered at once, massive hemorrhage protocol, or urgent blood request)
- Sex unknown or other than male or female (e.g., intersex)
- No valid Ontario Health Insurance Plan (OHIP) health card number
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
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
Follow-up
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
Trial Site Locations
Total: 8 locations
1
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Actively Recruiting
2
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
Not Yet Recruiting
3
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Not Yet Recruiting
4
Lakeridge Health Oshawa
Oshawa, Ontario, Canada, L1G 8A2
Not Yet Recruiting
5
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 1J8
Not Yet Recruiting
6
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Not Yet Recruiting
7
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Not Yet Recruiting
8
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Not Yet Recruiting
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Research Team
M
Michelle Zeller, Doctor of Medicine
B
Bambie Levoy-Jones, Honours Bachelor of Science
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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