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Traction Trial

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Recruitment

Closed to recruitment March 5, 2024.

Number of patients enrolled: 8428

Number of Sites: 10

Overview

A Phase IV trial of a hospital policy of Tranexamic acid use to reduce transfusion in major non-cardiac surgery (TRACTION)

Tranexamic Acid to Reduce Transfusion in Major Non-Cardiac Surgery

TRIAL SYNOPSIS

TitleA Phase IV trial of a hospital policy of Tranexamic acid use to reduce transfusion in major non-cardiac surgery (TRACTION)
Short titleTranexamic acid to reduce transfusion in major non-cardiac surgery
Trial designPragmatic, randomized cluster-crossover trial.
Planned sample size of trial participantsApproximately 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 AdministrationTXA 1 gram intravenous bolus followed by 1 additional gram prior to skin closure.
DurationFrom first surgical incision until skin closure.
Follow Up Duration90 days
Planned Trial Period18 months
Co-primary outcomesProportion of patients transfused red blood cells (RBCs); and

Incidence of deep vein thrombosis or pulmonary embolus within 3 months of surgery.
Secondary outcomesTransfusion: The number of RBC units transfused, both at an individual-level and at a cluster-level

Safety: In-hospital diagnosis of myocardial infarction, stroke, deep vein thrombosis or pulmonary embolus

Clinical: Hospital length of stay, ICU admission, hospital survival, 3-month survival, and the number of days at home to day 30 (DAH30)

Compliance: proportion of eligible patients who receive the policy intervention, and the policy compliance in enrolled patients.

FUNDERS AND COLLABORATORS

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MEDIA AND COMMUNICATIONS

TRACTION TEAM