Status:
UNKNOWN
An Innovative Trial Assessing Donor Sex on Recipient Mortality
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Canadian Blood Services
Conditions:
Red Blood Cell Transfusion
Eligibility:
All Genders
28+ years
Phase:
PHASE4
Brief Summary
The iTADS trial will test an important blood donor characteristic - donor sex - to see whether male donor blood leads to a greater benefit for transfusion recipients compared to female donor blood. T...
Detailed Description
The investigators have designed an innovative pragmatic randomized trial that will allocate transfusion recipients to receive either only male or only female donor transfusions. Primary objective: T...
Eligibility Criteria
Inclusion
- All patients (excluding neonates) requiring one or more allogeneic RBC transfusions for the treatment of anemia will be included.
Exclusion
- Patients that do not have a valid Ontario Health Insurance Plan (OHIP) number at time of first transfusion
- Patients that require emergent release of a RBC transfusion and in whom emergency randomization could not be completed
- Patients with complex antibody profile in which it is impossible to match RBC units
Key Trial Info
Start Date :
September 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
8850 Patients enrolled
Trial Details
Trial ID
NCT03344887
Start Date
September 4 2018
End Date
December 1 2022
Last Update
June 16 2022
Active Locations (1)
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1
Ottawa Hospital - General Campus
Ottawa, Ontario, Canada, K1H 8L6