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

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ClinicalTrials.gov Identifier: NCT03344887
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : September 7, 2018
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Canadian Blood Services
Information provided by (Responsible Party):
Dr. Dean Fergusson, Ottawa Hospital Research Institute

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8000 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
Estimated Primary Completion Date : September 4, 2020
Estimated Study Completion Date : March 4, 2021

Resource links provided by the National Library of Medicine


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.




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03344887


Contacts
Contact: Angie Tuttle (613) 737-8899 ext 75084 antuttle@ohri.ca

Locations
Canada, Ontario
Ottawa Hospital - General Campus Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Dean Fergusson, PhD    613-737-8480    dafergusson@ohri.ca   
Contact: Angie Tuttle    613-737-8899 ext 75084    antuttle@ohri.ca   
Principal Investigator: Dean A Fergusson, MHA, PhD         
Principal Investigator: Alan Tinmouth, MD, FRCPC, MSc         
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

Responsible Party: Dr. Dean Fergusson, Senior Scientist & Director, Clinical Epidemiology Program, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03344887     History of Changes
Other Study ID Numbers: 20170477-01H
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
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 Dr. Dean Fergusson, Ottawa Hospital Research Institute:
anemia
donor sex
prospective blinded pragmatic randomized