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Effects of Donor-recipient Sex-matched Blood Transfusion on Patient Outcomes

NCT06840756 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 11082

Last updated 2026-03-12

No results posted yet for this study

Summary

Red blood cell (RBC) transfusions are selected based upon matching donor and recipient blood group: donor and recipient sex are not considered when selecting blood for transfusion. Hence, transfused patients can currently receive sex-matched and/or unmatched RBCs when transfusions are given. Sex-matched stem cell transplants, and some solid organ transplants, have shown that sex-matching donor to recipient improves patient outcomes. Recent exploratory studies have also suggested that patient outcomes could be improved by sex-matching for RBC transfusion. There is emerging evidence of underlying biologic mechanism(s) to support these observations. This study is designed as a randomized controlled trial and will explore the impact on patients who receive RBC transfusions from donors of the same sex ("sex-matched") compared with donors of the opposite sex ("sex-mismatched").

The trial will study adult patients admitted to the Intensive Care Unit who require an RBC transfusion. Patients will be assigned (through a process called randomization) to receive sex-matched RBCs or sex-mismatched RBCs to determine if there is a difference in mortality between those receiving matched versus mismatched RBCs. The results of this trial could have direct implications on resources, blood inventory, and RBC transfusion ordering practices.

Conditions

  • Red Blood Cell Transfusions
  • Sex Differences
  • Health Services
  • Critically Ill Intensive Care Unit Patients
  • Hematology
  • Cardiovascular

Interventions

BIOLOGICAL

Sex-mismatched red blood cell transfusions

Sex-mismatched red blood cell transfusions

BIOLOGICAL

Sex-matched red blood cell transfusions

Sex-matched red blood cell transfusions

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Michelle Zeller

    lead OTHER

Principal Investigators

  • Michelle Zeller, Doctor of Medicine · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-11
Primary Completion
2028-12-31
Completion
2029-03-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06840756 on ClinicalTrials.gov