An Innovative Trial Assessing Donor Sex on Recipient Mortality — iTADS  

Red Blood Cell Transfusion Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Red Blood Cell Transfusion

• NCT number: NCT03344887
• Study type: Interventional
• Source: Ottawa Hospital Research Institute
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: September 4, 2018
• Completion date: December 1, 2022