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Status unknownNCT03344887iTADSUpdated Jun 16, 2022

An Innovative Trial Assessing Donor Sex on Recipient Mortality

A Phase 4 interventional study of RBC Transfusion from male donor and RBC Transfusion from female donor in Red Blood Cell Transfusion, sponsored by Ottawa Hospital Research Institute. Status unknown at 1 site in Canada. Open to participants aged 28 Days and older. Per ClinicalTrials.gov, last updated 2022-06-16.

Sponsored by Ottawa Hospital Research Institute · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
8,850
Allocation
Randomized
Ages
28 Days and older
Sex
All
01

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.

Read the 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.
02

Conditions studied

  • Red Blood Cell Transfusion

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Keywords

  • anemia
  • donor sex
  • prospective blinded pragmatic randomized
03

In context

Anemia

1,768 studies on the registry are indexed under Anemia; 244 are open to participants now.

This study's enrollment of 8,850 is above the median of 96 across 1,318 interventional studies indexed under Anemia.

Browse Anemia studies →

Lead sponsor

Ottawa Hospital Research Institute is the lead sponsor of 544 studies on the registry; 97 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
28 Days and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All patients (excluding neonates) requiring one or more allogeneic RBC transfusions for the treatment of anemia will be included.

Exclusion criteria

Exclusion Criteria:

  • Patients that do not have a valid Ontario Health Insurance Plan (OHIP) number at time of first transfusion
  • Patients that require emergent release of a RBC transfusion and in whom emergency randomization could not be completed
  • Patients with complex antibody profile in which it is impossible to match RBC units
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
8,850 participants (actual)

Study arms

  • Active comparator
    RBC Transfusion from male donor

    For the treatment of anemia

    Other: RBC Transfusion from male donor

  • Active comparator
    RBC Transfusion from female donor

    For the treatment of anemia

    Other: RBC Transfusion from female donor

Interventions

  • OtherRBC 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.

  • OtherRBC 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.

06

What researchers measure

Primary outcomes

  1. Survival

    Measured from date of first randomization to date of death or end of study 2 years from first patient enrollment.

    Time frame: 2 years

Secondary outcomes

  1. Survival

    Measured from date of first randomization to date of death or end of study 2 years from the first patient enrollment.

    Time frame: 30 days, 3 months, 6 months and 1 year

  2. Length of hospital stay

    Number of days admitted to hospital for the treatment of anemia.

    Time frame: 2 years

  3. New ICU admission

    Occurrence of ICU admission(s) once discharged for the treatment of anemia.

    Time frame: 2 years

  4. Re-hospitalization

    Occurrence of additional hospital admission(s) once discharged for the treatment of anemia.

    Time frame: 2 years

  5. Health system costs

    The cost of the treatment of anemia and any related downstream health care resources.

    Time frame: 2 years

  6. Occurrence of new cancer

    The number of new cancer diagnoses, not present during the initial treatment of anemia.

    Time frame: 2 years

  7. Recurrence of cancer

    The number of repeat cancer diagnoses, diagnosed previous to the initial treatment of anemia.

    Time frame: 2 years

  8. Infection rates

    Methicillin-resistant Staphylococcus aureus and Clostridium difficile for hospital-acquired infections.

    Time frame: 2 years

  9. New occurrence of hemodialysis

    For severe chronic renal failure.

    Time frame: 2 years

  10. Myocardial infarctions

    For cardiac events.

    Time frame: 2 years

07

Study locations

1 site
  • Ottawa Hospital - General Campus
    Ottawa, Ontario K1H 8L6, Canada
08

References and documents

Publications

  • Chasse M, Fergusson DA, Tinmouth A, Acker JP, Perelman I, Tuttle A, English SW, Hawken S, Forster AJ, Shehata N, Thavorn K, Wilson K, Cober N, Maddison H, Tokessy M. Effect of Donor Sex on Recipient Mortality in Transfusion. N Engl J Med. 2023 Apr 13;388(15):1386-1395. doi: 10.1056/NEJMoa2211523. PubMed 37043654 ↗
  • Fergusson DA, Chasse M, Tinmouth A, Acker JP, English S, Forster AJ, Hawken S, Shehata N, Thavorn K, Wilson K, Tuttle A, Perelman I, Cober N, Maddison H, Tokessy M. 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. BMJ Open. 2021 Feb 23;11(2):e049598. doi: 10.1136/bmjopen-2021-049598. PubMed 33622960 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03344887
Lead sponsor
Ottawa Hospital Research Institute
Collaborators
Canadian Institutes of Health Research (CIHR), Canadian Blood Services
Responsible party
Sponsor
First posted
Nov 17, 2017
Start date
Sep 4, 2018
Primary completion
Jan 23, 2021
Completion
Dec 1, 2022 (estimated)
Last update
Jun 16, 2022

Study contacts

Michaël Chassé
principal investigator · Centre hospitalier de l'Université de Montréal (CHUM)
Dean Fergusson
principal investigator · Ottawa Hospital Research Institute
Alan Tinmouth
principal investigator · Ottawa Hospital Research Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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