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

• ClinicalTrials.gov Identifier: NCT03344887
• Recruitment Status: Active, not recruiting
• First Posted: November 17, 2017
• Last Update Posted: October 8, 2021
• Sponsor: Ottawa Hospital Research Institute
• Collaborators: Canadian Institutes of Health Research (CIHR); Canadian Blood Services
• Information provided by (Responsible Party): Ottawa Hospital Research Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Red Blood Cell Transfusion	Other: RBC Transfusion from male donor; Other: RBC Transfusion from female donor	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 8850 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: An Innovative Trial Assessing Donor Sex on Recipient Mortality (iTADS)
• Actual Study Start Date: September 4, 2018
• Actual Primary Completion Date: January 23, 2021
• Estimated Study Completion Date: December 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Survival [ Time Frame: 2 years ]
   Measured from date of first randomization to date of death or end of study 2 years from first patient enrollment.

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Canada, Ontario

Ottawa Hospital - General Campus

Ottawa, Ontario, Canada, K1H 8L6

Sponsors and Collaborators

Ottawa Hospital Research Institute

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fergusson DA, Chassé 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.

• Responsible Party: Ottawa Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT03344887
• Other Study ID Numbers: 20170477-01H
• First Posted: November 17, 2017
• Last Update Posted: October 8, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ottawa Hospital Research Institute:

anemia; donor sex; prospective blinded pragmatic randomized