NCT03344887

An Innovative Trial Assessing Donor Sex on Recipient Mortality

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 8,850 (actual)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 28 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Red Blood Cell Transfusion

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2018-09-04
• Primary completion: 2021-01-23
• Completion: 2022-12-01
• First posted: 2017-11-17
• Last updated: 2022-06-16

Locations

1 site across 1 country: Canada