Sex-Matched Blood Transfusions for Critically Ill Patients

(SexMATTERS RCT Trial)

Recruiting at 7 trial locations

Overseen By Michelle Zeller, Doctor of Medicine

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Michelle Zeller

Disqualifiers: Rare blood type, Massive bleeding, Intersex, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

11082 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is it safe to receive sex-matched or sex-mismatched blood transfusions?

Some studies suggest that receiving blood from a donor of a different sex might be linked to higher risks, like increased mortality, but the exact reasons are not fully understood. More research is needed to understand the safety of sex-mismatched blood transfusions. ^{1 2 3 4 5}

How is the treatment of sex-matched blood transfusions different from other treatments for critically ill patients?

This treatment is unique because it involves matching the sex of the blood donor with the recipient, which is not typically done in standard blood transfusions. Research suggests that sex-mismatched transfusions may increase mortality, possibly due to effects on the blood vessels, making sex-matched transfusions a potentially safer option for critically ill patients. ^{2 3 6 7 8}

What data supports the effectiveness of the treatment Sex-matched red blood cell transfusions for critically ill patients?

Research suggests that sex-mismatched blood transfusions may be linked to higher mortality rates in critically ill patients, possibly due to biological differences between male and female blood. This implies that sex-matched transfusions could potentially reduce these risks and improve outcomes. ^{1 2 3 4 9}

Who Is on the Research Team?

Michelle Zeller, Doctor of Medicine

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

Adult patients in the Intensive Care Unit who need a red blood cell (RBC) transfusion can join this trial. The study is looking at whether getting RBCs from donors of the same sex ('sex-matched') versus the opposite sex ('sex-mismatched') affects patient outcomes.

Inclusion Criteria

Admission to a participating ICU

I need a red blood cell transfusion.

Exclusion Criteria

I need a special type of blood product that is hard to find.

My sex is not strictly male or female.

Do not have a valid Ontario Health Insurance Plan (OHIP) health card number

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Treatment

Participants are randomized to receive either sex-matched or sex-mismatched RBC transfusions

Up to 90 days

Ongoing monitoring during ICU stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including mortality and other outcomes

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Sex-matched red blood cell transfusions
• Sex-mismatched red blood cell transfusions

Trial Overview The trial is testing if 'sex-matched' RBC transfusions lead to better health results than 'sex-mismatched' ones for ICU patients. Participants will be randomly assigned to receive either matched or mismatched RBCs, and researchers will compare mortality rates between these two groups.

How Is the Trial Designed?

Group I: Sex-matched Experimental Treatment 1 Intervention

Sex-matched red blood cell transfusion

Group II: Sex-mismatched Active Control 1 Intervention

Sex-mismatched red blood cell transfusion

Who Is Running the Clinical Trial?

Michelle Zeller

Lead Sponsor

Trials

1

Recruited

11,100+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Citations

1. United States pubmed.ncbi.nlm.nih.gov

The association between blood donor sex and age and transfusion recipient mortality: an exploratory analysis. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Association of red blood cell transfusion and in-hospital mortality in patients admitted to the intensive care unit: a systematic review and meta-analysis. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of Sex-Mismatched Red Blood Cell Transfusion on Endothelial Cell Activation in Critically Ill Patients. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Sex-mismatched red blood cell transfusions and mortality: A systematic review and meta-analysis. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Biological mechanisms implicated in adverse outcomes of sex mismatched transfusions. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Effect of Donor Sex on Recipient Mortality in Transfusion. [2023]

7. Jamaica pubmed.ncbi.nlm.nih.gov

Red cell transfusion practices and the impact of phlebotomy in an adult intensive care unit in Trinidad--a prospective observational study. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Donor-recipient sex is associated with transfusion-related outcomes in critically ill patients. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Determinants of red blood cell transfusions in a pediatric critical care unit: a prospective, descriptive epidemiological study. [2019]