Sex-Matched Blood Transfusions for Critically Ill Patients

(SexMATTERS RCT Trial)

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether blood transfusions from donors of the same sex can improve outcomes for critically ill patients in the ICU. It compares the effects of receiving blood from a donor of the same sex ("sex-matched") versus the opposite sex ("sex-mismatched") on survival rates. The findings could change how blood transfusions are ordered and managed, potentially increasing their effectiveness. The trial seeks adult participants admitted to the ICU who need a blood transfusion. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and this research aims to understand how it can benefit more patients.

Will I have to stop taking my current medications?

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

What is the safety track record for these treatments?

Research suggests that matching the sex of blood donors and recipients might be safer. One study found that male patients who received blood from female donors had a higher risk of dying in the ICU compared to those who received blood from male donors. Another study found no difference in survival between male and female donors, but it did not specifically focus on matching donor and recipient sex.

Receiving blood from a donor of a different sex might be linked to a higher risk of death. Some studies suggest that these mismatched transfusions could increase the risk of dying, although the evidence remains weak.

Both sex-matched and sex-mismatched transfusions are currently used, but safety concerns may exist with mismatching. This trial aims to explore these differences further. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about sex-matched blood transfusions for critically ill patients because they could potentially improve outcomes by matching the donor's and recipient's biological sex. Most current transfusion practices don't consider sex differences, and this trial is exploring whether matching the sex of transfused blood could reduce complications and improve recovery times. By focusing on the compatibility of sex-specific blood components, this approach could lead to more personalized and effective transfusion strategies, offering a tailored treatment that isn't part of the standard procedure today.

What evidence suggests that this trial's treatments could be effective for critically ill patients requiring RBC transfusions?

This trial will compare sex-matched red blood cell transfusions with sex-mismatched transfusions for critically ill patients. Research has suggested that matching the sex of blood donors and recipients might aid recovery in critically ill patients. Some studies have indicated that male patients receiving blood from female donors may face a higher risk of dying in the ICU compared to those receiving blood from male donors. However, other studies have not found a significant difference in survival based on the donor's sex. The hypothesis is that matching donor and recipient by sex might align better with the body's natural processes. This research is ongoing, and more information is needed to confirm these findings. ^{1 2 5 6 7}

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. clinicaltrials.gov clinicaltrials.gov/study/NCT06840756?cond=Critical%20Illness&viewType=Table&term=BLOOD%20CELLS,%20RED&rank=4

Effects of Donor-recipient Sex-matched Blood Transfusion ... Importance & Outcomes: Anemia is common in critically ill patients; as many as 90% of patients will become anemic by the third day of their ICU admission.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9198942/

Donor-recipient sex is associated with transfusion-related ... Key Points. Transfusion of female RBCs to male recipients increases the risk of ICU mortality compared with female blood to female recipients.

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/jha2.1005

The association of donor and recipient sex on sepsis rates ... Blood donor sex was not associated with HO-sepsis in critically ill patients receiving RBC transfusion. Male to female transfusions were associated with a ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2211523

Effect of Donor Sex on Recipient Mortality in Transfusion This trial showed no significant difference in survival between a transfusion strategy involving red-cell units from female donors and a strategy involving red ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1473050224001939

Sex discrepancies in blood donation: Implications for red ... This review explores the impact of donor sex and donor-recipient sex mismatch on RBC characteristics and transfusion outcomes.

6. jtcvs.org jtcvs.org/article/S0022-5223(16)30028-9/fulltext

Sex matching and red cell safety Red blood cell transfusions worsen the outcomes even in critically ill patients undergoing a restrictive transfusion strategy. Sao Paulo Med J. 2012; 130:77 ...

7. annsaudimed.net annsaudimed.net/doi/10.5144/0256-4947.2024.84

Does red blood cell transfusion affect clinical outcomes in ... Does red blood cell transfusion affect clinical outcomes in critically ill patients? A report from a large teaching hospital in south Iran.