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Blood Transfusion
Red blood cells for Blood Transfusion
Phase < 1
Waitlist Available
Led By Michelle Zeller, MD
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Requiring a red blood cell transfusion
Adults (age ≥18)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of study initiation at each site until date the final patient is randomized, approximately 8 months.
Awards & highlights
Study Summary
This study is evaluating whether giving male patients female blood and female patients male blood (sex-mismatched blood) is better for patients than giving male patients male blood and female patients female blood (sex-matched blood).
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of study initiation at each site until date the final patient is randomized, approximately 8 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of study initiation at each site until date the final patient is randomized, approximately 8 months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility outcome - Missing randomization rate (%)
Feasibility outcome - Protocol adherence (%)
Feasibility outcome - Recruitment compliance (%)
Other outcome measures
Data collection outcome - Ability to provide timely monthly reports
Data collection outcome - Rate of post-randomization exclusions (%)
Patient important clinical outcomes - Creatinine level and increment (umol/L)
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Sex-mismatched red blood cell transfusionExperimental Treatment1 Intervention
All patients will receive red blood cells (RBCs) that are ABO and Rh compatible as per routine blood bank practices. In addition to routine compatibility, subjects in this arm will receive blood that is not matched to their sex (donor and recipient sex are not the same). Patients in this arm will receive RBCs mismatched to their sex until discharge from hospital or death.
Group II: Sex-matched red blood cell transfusionExperimental Treatment1 Intervention
All patients will receive red blood cells (RBCs) that are ABO and Rh compatible as per routine blood bank practices. In addition to routine compatibility, subjects in this arm will receive blood that is matched to their sex (donor and recipient sex are the same). Patients in this arm will receive RBCs matched to their sex until discharge from hospital or death.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Red blood cells
2022
Completed Early Phase 1
~270
Find a Location
Who is running the clinical trial?
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,336 Previous Clinical Trials
25,750,838 Total Patients Enrolled
McMaster UniversityLead Sponsor
879 Previous Clinical Trials
2,596,440 Total Patients Enrolled
Michelle Zeller, MDPrincipal InvestigatorMcMaster University
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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