Clinical trial NCT03344887: An Innovative Trial Assessing Donor Sex on Recipient Mortality
Official title: An Innovative Trial Assessing Donor Sex on Recipient Mortality (iTADS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Red Blood Cell Transfusion
Keywords: anemia
donor sex
prospective blinded pragmatic randomized
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Canadian Blood Services
First posted: 2017-11-17
Enrollment: 8850
Sex: ALL
Minimum age (years): 28
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Survival
timeFrame: 2 years
Secondary outcomes:
measure: Survival
timeFrame: 30 days, 3 months, 6 months and 1 year
measure: Length of hospital stay
timeFrame: 2 years
measure: New ICU admission
timeFrame: 2 years
measure: Re-hospitalization
timeFrame: 2 years
measure: Health system costs
timeFrame: 2 years
measure: Occurrence of new cancer
timeFrame: 2 years
measure: Recurrence of cancer
timeFrame: 2 years
measure: Infection rates
timeFrame: 2 years
measure: New occurrence of hemodialysis
timeFrame: 2 years
measure: Myocardial infarctions
timeFrame: 2 years
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital - General Campus
state: Ontario
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Michaël Chassé
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Hospital Research Institute
name: Dean Fergusson
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Hospital Research Institute
name: Alan Tinmouth
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.