NCT03344887|UnknownPhase 4DMC
An Innovative Trial Assessing Donor Sex on Recipient Mortality
iTADS
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Sponsor study identifier
interventional
8,850
1 country
1
Study Start
September 4, 2018
Actual (reported)Primary Completion
January 23, 2021
Actual (reported)Study Completion
December 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 14, 2017
Actual (reported)November 17, 2017
Actual (reported)September 4, 2018
Actual (reported)January 23, 2021
Actual (reported)December 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Survival
Measured from date of first randomization to date of death or end of study 2 years from first patient enrollment.
2 years
Survival
30 days, 3 months, 6 months and 1 year
Length of hospital stay
2 years
New ICU admission
2 years
Re-hospitalization
2 years
Health system costs
2 years
For the treatment of anemia
For the treatment of anemia
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.
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.
Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6, Canada
Chasse M, Fergusson DA, Tinmouth A, Acker JP, Perelman I, Tuttle A, English SW, Hawken S, Forster AJ, Shehata N, Thavorn K, Wilson K, Cober N, Maddison H, Tokessy M. Effect of Donor Sex on Recipient Mortality in Transfusion. N Engl J Med. 2023 Apr 13;388(15):1386-1395. doi: 10.1056/NEJMoa2211523.
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.
Michaël Chassé
Centre hospitalier de l'Université de Montréal (CHUM)
Dean Fergusson
Ottawa Hospital Research Institute
Alan Tinmouth
Ottawa Hospital Research Institute
8,850 participants (actual enrollment reported by the registry).
First Submitted
November 14, 2017
First Posted
November 17, 2017
Study Start
September 4, 2018
Actual (reported)Effects of Donor-recipient Sex-matched Blood Transfusion on Patient Outcomes
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
January 23, 2021
Actual (reported)Study Completion
December 1, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 16, 2022
Record last verified: 2022-06
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Source: ClinicalTrials.gov.
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