An Innovative Trial Assessing Donor Sex on Recipient Mortality

Red Blood Cell Transfusion Clinical Trial

— iTADS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03344887
• Other study ID #: 20170477-01H
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: September 4, 2018
• Est. completion date: December 1, 2022

Study information

• Verified date: June 2022
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8850
• Est. completion date: December 1, 2022
• Est. primary completion date: January 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Red Blood Cell Transfusion

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Ottawa Hospital - General Campus	Ottawa	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Canadian Blood Services, Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

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