Red Blood Cell Transfusion
Conditions
Keywords
anemia, donor sex, prospective blinded pragmatic randomized
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.
Interventions
OTHERRBC Transfusion from male donor
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.
OTHERRBC Transfusion from female donor
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.
Sponsors
Canadian Institutes of Health Research (CIHR)
Canadian Blood Services
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
28 Days to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival | 2 years | Measured from date of first randomization to date of death or end of study 2 years from first patient enrollment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of new cancer | 2 years | The number of new cancer diagnoses, not present during the initial 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. |
| Length of hospital stay | 2 years | Number of days admitted to hospital for the treatment of anemia. |
| New ICU admission | 2 years | Occurrence of ICU admission(s) once discharged for the treatment of anemia. |
| Health system costs | 2 years | The cost of the treatment of anemia and any related downstream health care resources. |
| 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. |
| New occurrence of hemodialysis | 2 years | For severe chronic renal failure. |
| Myocardial infarctions | 2 years | For cardiac events. |
| Re-hospitalization | 2 years | Occurrence of additional hospital admission(s) once discharged for the treatment of anemia. |
Countries
Canada
Outcome results
None listed