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

Funders & Collaborators

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.