An Innovative Trial Assessing Donor Sex on Recipient Mortality
- Conditions
- Red Blood Cell Transfusion
- Interventions
- Other: RBC Transfusion from male donorOther: RBC Transfusion from female donor
- Registration Number
- NCT03344887
- Lead Sponsor
- Ottawa Hospital Research Institute
- 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.
The trial will help determine how the investigators can tailor the selection of blood donors based on donor characteristics (e.g. sex) to further improve the safety and optimize the clinical benefit of blood products in Canada.
- 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:
To confirm that a transfusion strategy of receiving male donor RBC (Red Blood Cell) units only will improve survival compared to a transfusion strategy of female donor RBC units in all hospital patients requiring a transfusion.
Secondary objectives:
1. To assess effects of male RBC units on major morbidities (cancer, infection, end-organ damage)
2. To assess effects across major patient subgroups (major surgery, intensive care, oncology)
3. To assess the effect of female donor pregnancy history on recipient transfusion outcome
4. To build capacity to conduct large innovative prospective pragmatic clinical trials in transfusion medicine using routinely collected clinical and administrative information.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 8850
- All patients (excluding neonates) requiring one or more allogeneic RBC transfusions for the treatment of anemia will be included.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RBC Transfusion from male donor RBC Transfusion from male donor For the treatment of anemia RBC Transfusion from female donor RBC Transfusion from female donor For the treatment of anemia
- Primary Outcome Measures
Name Time Method Survival 2 years Measured from date of first randomization to date of death or end of study 2 years from first patient enrollment.
- Secondary Outcome Measures
Name Time Method Myocardial infarctions 2 years For cardiac events.
Length of hospital stay 2 years Number of days admitted to hospital for the treatment of anemia.
Survival 30 days, 3 months, 6 months and 1 year Measured from date of first randomization to date of death or end of study 2 years from the first patient enrollment.
Health system costs 2 years The cost of the treatment of anemia and any related downstream health care resources.
New occurrence of hemodialysis 2 years For severe chronic renal failure.
New ICU admission 2 years Occurrence of ICU admission(s) once discharged for the treatment of anemia.
Re-hospitalization 2 years Occurrence of additional hospital admission(s) once discharged for the treatment of anemia.
Occurrence of new cancer 2 years The number of new cancer diagnoses, not present during the initial treatment of anemia.
Recurrence of cancer 2 years The number of repeat cancer diagnoses, diagnosed previous to the initial treatment of anemia.
Infection rates 2 years Methicillin-resistant Staphylococcus aureus and Clostridium difficile for hospital-acquired infections.
Trial Locations
- Locations (1)
Ottawa Hospital - General Campus
🇨🇦Ottawa, Ontario, Canada