A Phase IV trial of a hospital policy of Tranexamic acid to reduce transfution in major non-cardiac surgery (TRACTION)
A Pragmatic randomized controlled trial
Trial Overview
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8428 Patients Enrolled - Complete
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10 Participating Sites
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OHRI Database
Funders & Collaborators
Trial Description
The TRACTION Trial was a national multi-centre Phase IV randomized cluster-crossover trial comparing Tranexamic acid versus placebo. Participating centres were randomly allocated to receive either TXA or matching placebo at 1-month intervals, with co-primary outcomes designed to evaluate effectiveness in the context of safety.
Trial Synopsis
● TITLE: A Phase IV trial of a hospital policy of Tranexamic acid use to reduce transfusion in major non-cardiac surgery (TRACTION)
● SHORT TITLE: Tranexamic acid to reduce transfusion in major non-cardiac surgery
● TRIAL DESIGN: Pragmatic, randomized cluster-crossover trial.
● PLANNED SAMPLE SIZE OF TRIAL PARTICIPANTS: Approximately 8320 patients 18 years of age and with Increased local fibrinolysis undergoing surgeries known to have a baseline transfusion rate of 5% or greater.
● INVESTIGATIONAL MEDICINAL PRODUCT(s): Tranexamic acid (TXA)
● FORMULATION, DOSE, ROUTE OF ADMINISTRATION: TXA 1 gram intravenous bolus followed by 1 additional gram prior to skin closure.
● DURATION: From first surgical incision until skin closure.
● FOLLOW UP DURATION: 90 days
● PLANNED TRIAL PERIOD: 18 months
● PRIMARY OUTCOMES: Co-primary outcomes include: a) the proportion of patients transfused red blood cells (RBCs); and b) the incidence of deep vein thrombosis or pulmonary embolus within 3 months of surgery.
● SECONDARY OUTCOMES: (1) Transfusion: The number of RBC units transfused, both at an individual-level and at a cluster-level; (2) Safety: In-hospital diagnosis of myocardial infarction, stroke, deep vein thrombosis or pulmonary embolus; (3) Clinical: Hospital length of stay, ICU admission, hospital survival, 3-month survival, and the number of days at home to day 30 (DAH30); 4) Compliance: proportion of eligible patients who receive the policy intervention, and the policy compliance in enrolled patients.
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A Phase IV trial of a hospital policy of Tranexamic acid use to reduce transfusion in major non-cardiac surgery (TRACTION)
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Tranexamic acid to reduce transfusion in major non-cardiac surgery
-
Pragmatic, randomized cluster-crossover trial.
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Approximately 8320 patients 18 years of age and with Increased local fibrinolysis undergoing surgeries known to have a baseline transfusion rate of 5% or greater.
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Tranexamic acid (TXA)
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TXA 1 gram intravenous bolus followed by 1 additional gram prior to skin closure.
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From first surgical incision until skin closure.
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90 days
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18 months
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Co-primary outcomes include: a) the proportion of patients transfused red blood cells (RBCs); and b) the incidence of deep vein thrombosis or pulmonary embolus within 3 months of surgery.
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(1) Transfusion: The number of RBC units transfused, both at an individual-level and at a cluster-level; (2) Safety: In-hospital diagnosis of myocardial infarction, stroke, deep vein thrombosis or pulmonary embolus; (3) Clinical: Hospital length of stay, ICU admission, hospital survival, 3-month survival, and the number of days at home to day 30 (DAH30); 4) Compliance: proportion of eligible patients who receive the policy intervention, and the policy compliance in enrolled patients.