An Innovative Trial Assessing Donor Sex on Recipient Mortality (iTADS)
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|ClinicalTrials.gov Identifier: NCT03344887|
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : September 7, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Red Blood Cell Transfusion||Other: RBC Transfusion from male donor Other: RBC Transfusion from female donor||Phase 4|
The investigators have designed an innovative pragmatic randomized trial that will allocate transfusion recipients to receive either only male or only female donor transfusions.
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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||An Innovative Trial Assessing Donor Sex on Recipient Mortality (iTADS)|
|Actual Study Start Date :||September 4, 2018|
|Estimated Primary Completion Date :||September 4, 2020|
|Estimated Study Completion Date :||March 4, 2021|
Active Comparator: RBC Transfusion from male donor
For the treatment of anemia
Other: RBC 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.
Active Comparator: RBC Transfusion from female donor
For the treatment of anemia
Other: RBC 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.
- Survival [ Time Frame: 2 years ]Measured from date of first randomization to date of death or end of study 2 years from first patient enrollment.
- Survival [ Time Frame: 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 [ Time Frame: 2 years ]Number of days admitted to hospital for the treatment of anemia.
- New ICU admission [ Time Frame: 2 years ]Occurrence of ICU admission(s) once discharged for the treatment of anemia.
- Re-hospitalization [ Time Frame: 2 years ]Occurrence of additional hospital admission(s) once discharged for the treatment of anemia.
- Health system costs [ Time Frame: 2 years ]The cost of the treatment of anemia and any related downstream health care resources.
- Occurrence of new cancer [ Time Frame: 2 years ]The number of new cancer diagnoses, not present during the initial treatment of anemia.
- Recurrence of cancer [ Time Frame: 2 years ]The number of repeat cancer diagnoses, diagnosed previous to the initial treatment of anemia.
- Infection rates [ Time Frame: 2 years ]Methicillin-resistant Staphylococcus aureus and Clostridium difficile for hospital-acquired infections.
- New occurrence of hemodialysis [ Time Frame: 2 years ]For severe chronic renal failure.
- Myocardial infarctions [ Time Frame: 2 years ]For cardiac events.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03344887
|Contact: Angie Tuttle||(613) 737-8899 ext email@example.com|
|Ottawa Hospital - General Campus||Recruiting|
|Ottawa, Ontario, Canada, K1H 8L6|
|Contact: Dean Fergusson, PhD 613-737-8480 firstname.lastname@example.org|
|Contact: Angie Tuttle 613-737-8899 ext 75084 email@example.com|
|Principal Investigator: Dean A Fergusson, MHA, PhD|
|Principal Investigator: Alan Tinmouth, MD, FRCPC, MSc|
|Principal Investigator:||Michaël Chassé||Centre hospitalier de l'Université de Montréal (CHUM)|
|Principal Investigator:||Dean Fergusson||Ottawa Hospital Research Institute|
|Principal Investigator:||Alan Tinmouth||Ottawa Hospital Research Institute|