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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Red Blood Cell Transfusion
• Intervention / Treatment: Other: RBC Transfusion from male donor; Other: RBC Transfusion from female donor

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.

• Study Type: Interventional
• Enrollment (Actual): 8850
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: RBC Transfusion from male donor; For the treatment of anemia	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.
ACTIVE_COMPARATOR: RBC Transfusion from female donor; For the treatment of anemia	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Measured from date of first randomization to date of death or end of study 2 years from first patient enrollment.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Measured from date of first randomization to date of death or end of study 2 years from the first patient enrollment.	30 days, 3 months, 6 months and 1 year
Length of hospital stay	Number of days admitted to hospital for the treatment of anemia.	2 years
New ICU admission	Occurrence of ICU admission(s) once discharged for the treatment of anemia.	2 years
Re-hospitalization	Occurrence of additional hospital admission(s) once discharged for the treatment of anemia.	2 years
Health system costs	The cost of the treatment of anemia and any related downstream health care resources.	2 years
Occurrence of new cancer	The number of new cancer diagnoses, not present during the initial treatment of anemia.	2 years
Recurrence of cancer	The number of repeat cancer diagnoses, diagnosed previous to the initial treatment of anemia.	2 years
Infection rates	Methicillin-resistant Staphylococcus aureus and Clostridium difficile for hospital-acquired infections.	2 years
New occurrence of hemodialysis	For severe chronic renal failure.	2 years
Myocardial infarctions	For cardiac events.	2 years

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Collaborators: Canadian Institutes of Health Research (CIHR); Canadian Blood Services
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 4, 2018
• Primary Completion (ACTUAL): January 23, 2021
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: November 14, 2017
• First Submitted That Met QC Criteria: November 14, 2017
• First Posted (ACTUAL): November 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 16, 2022
• Last Update Submitted That Met QC Criteria: June 15, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: anemia; donor sex; prospective blinded pragmatic randomized
• Other Study ID Numbers: 20170477-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No