NCT03344887

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8,850

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2018

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

September 4, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2021

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

June 16, 2022

Status Verified

June 1, 2022

Enrollment Period

2.4 years

First QC Date

November 14, 2017

Last Update Submit

June 15, 2022

Conditions

Red Blood Cell Transfusion

Keywords

anemiadonor sexprospective blinded pragmatic randomized

Outcome Measures

Primary Outcomes (1)

  • Survival

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

    2 years

Secondary Outcomes (10)

  • Survival

    30 days, 3 months, 6 months and 1 year

  • Length of hospital stay

    2 years

  • New ICU admission

    2 years

  • Re-hospitalization

    2 years

  • Health system costs

    2 years

  • +5 more secondary outcomes

Study Arms (2)

RBC Transfusion from male donor

ACTIVE COMPARATOR

For the treatment of anemia

Other: RBC Transfusion from male donor

RBC Transfusion from female donor

ACTIVE COMPARATOR

For the treatment of anemia

Other: RBC Transfusion from female donor

Interventions

RBC Transfusion from male donorOTHER

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.

RBC Transfusion from male donor
RBC Transfusion from female donorOTHER

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.

RBC Transfusion from female donor

Eligibility Criteria

Age28 Days+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Publications (2)

  • 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.

    PMID: 37043654DERIVED

  • 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.

    PMID: 33622960DERIVED

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Michaël Chassé

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

  • Dean Fergusson

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

  • Alan Tinmouth

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2017

First Posted

November 17, 2017

Study Start

September 4, 2018

Primary Completion

January 23, 2021

Study Completion

December 1, 2022

Last Updated

June 16, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)