NCT06840756 Effects of Donor-recipient Sex-matched Blood Transfusion on Patient Outcomes
| NCT ID | NCT06840756 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Michelle Zeller |
| Condition | Red Blood Cell Transfusions |
| Study Type | INTERVENTIONAL |
| Enrollment | 11,082 participants |
| Start Date | 2025-09-11 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 11,082 participants in total. It began in 2025-09-11 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Adults (age ≥18); * Admission to a participating ICU; * Requiring RBC transfusion. Exclusion Criteria: * Requirement for a specialized RBC product or unit not readily available in inventory (e.g., rare blood type, washed RBCs, complex RBC antibodies, etc.); * Massively bleeding patient (i.e., ≥4 units of blood ordered at one time, or Massive Hemorrhage Protocol initiated, or an urgent blood request made); * Sex unknown or sex other than male or female (i.e. intersex); * Do not have a valid Ontario Health Insurance Plan (OHIP) health card number.
Contact & Investigator
Michelle Zeller, Doctor of Medicine
PRINCIPAL INVESTIGATOR
McMaster University
Frequently Asked Questions
Who can join the NCT06840756 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Red Blood Cell Transfusions. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06840756 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06840756 currently recruiting?
Yes, NCT06840756 is actively recruiting participants. Contact the research team at zeller@mcmaster.ca for enrollment information.
Where is the NCT06840756 trial being conducted?
This trial is being conducted at Hamilton, Canada, Kingston, Canada, London, Canada, Oshawa, Canada and 4 additional locations.
Who is sponsoring the NCT06840756 clinical trial?
NCT06840756 is sponsored by Michelle Zeller. The principal investigator is Michelle Zeller, Doctor of Medicine at McMaster University. The trial plans to enroll 11,082 participants.