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An Innovative Trial Assessing Donor Sex on Recipient Mortality

NCT03344887 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 8850

Last updated 2022-06-16

No results posted yet for this study

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.

Conditions

  • Red Blood Cell Transfusion

Interventions

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.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Canadian Blood Services

    collaborator OTHER

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Michaël Chassé · Centre hospitalier de l'Université de Montréal (CHUM)

  • Dean Fergusson · Ottawa Hospital Research Institute

  • Alan Tinmouth · Ottawa Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-04
Primary Completion
2021-01-23
Completion
2022-12-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03344887 on ClinicalTrials.gov