An Innovative Trial Assessing Donor Sex on Recipient Mortality

Study Overview
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Brief Summary
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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
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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: To assess effects of male RBC units on major morbidities (cancer, infection, end-organ damage) To assess effects across major patient subgroups (major surgery, intensive care, oncology) To assess the effect of female donor pregnancy history on recipient transfusion outcome To build capacity to conduct large innovative prospective pragmatic clinical trials in transfusion medicine using routinely collected clinical and administrative information.

Official Title
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An Innovative Trial Assessing Donor Sex on Recipient Mortality (iTADS)

Conditions
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Red Blood Cell Transfusion

Intervention / Treatment
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* Other: RBC Transfusion from male donor
* Other: RBC Transfusion from female donor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients (excluding neonates) requiring one or more allogeneic RBC transfusions for the treatment of anemia will be included. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RBC Transfusion from male donor<br>For the treatment of anemia | Other: RBC Transfusion from male donor<br>* Patients requiring an RBC transfusion for the treatment of anemia will receive products from a male donor at initial and any subsequent hospitalizations during the trial period.<br>|
| Active Comparator: RBC Transfusion from female donor<br>For the treatment of anemia | Other: RBC Transfusion from female donor<br>* Patients requiring an RBC transfusion for the treatment of anemia will receive products from a female donor at initial and any subsequent hospitalizations during the trial period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Measured from date of first randomization to date of death or end of study 2 years from first patient enrollment. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Measured from date of first randomization to date of death or end of study 2 years from the first patient enrollment. | 30 days, 3 months, 6 months and 1 year | 
| Length of hospital stay | Number of days admitted to hospital for the treatment of anemia. | 2 years | 
| New ICU admission | Occurrence of ICU admission(s) once discharged for the treatment of anemia. | 2 years | 
| Re-hospitalization | Occurrence of additional hospital admission(s) once discharged for the treatment of anemia. | 2 years | 
| Health system costs | The cost of the treatment of anemia and any related downstream health care resources. | 2 years | 
| Occurrence of new cancer | The number of new cancer diagnoses, not present during the initial treatment of anemia. | 2 years | 
| Recurrence of cancer | The number of repeat cancer diagnoses, diagnosed previous to the initial treatment of anemia. | 2 years | 
| Infection rates | Methicillin-resistant Staphylococcus aureus and Clostridium difficile for hospital-acquired infections. | 2 years | 
| New occurrence of hemodialysis | For severe chronic renal failure. | 2 years | 
| Myocardial infarctions | For cardiac events. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anemia, donor sex, prospective blinded pragmatic randomized