Last reviewed · How we verify

NCT03344887: iTADS

An Innovative Trial Assessing Donor Sex on Recipient Mortality

Status unknown Phase 4 Last updated 16 June 2022
What this trial tests

Phase 4 trial testing RBC Transfusion from male donor in Red Blood Cell Transfusion in 8,850 participants. Status unknown.

Timeline
4 September 2018
Primary endpoint
23 January 2021
1 December 2022

Quick facts

Lead sponsorOttawa Hospital Research Institute
PhasePhase 4
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment8,850
Start date4 September 2018
Primary completion23 January 2021
Estimated completion1 December 2022
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

Ottawa Hospital Research Institute

Who can join

28 Days and older, any sex, with Red Blood Cell Transfusion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Effect of Donor Sex on Recipient Mortality in Transfusion.
    Chassé M, Fergusson DA, Tinmouth A, Acker JP, et al · · 2023 · cited 18× · PMID 37043654 · DOI 10.1056/nejmoa2211523
  2. Pragmatic, double-blind, randomised trial evaluating the impact of red blood cell donor sex on recipient mortality in an academic hospital population: the innovative Trial Assessing Donor Sex (iTADS) protocol.
    Fergusson DA, Chassé M, Tinmouth A, Acker JP, et al · · 2021 · cited 10× · PMID 33622960 · DOI 10.1136/bmjopen-2021-049598

Verify or expand the search:

Other Ottawa Hospital Research Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03344887.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing