A Phase IV trial of a hospital policy of tranexamic acid use to reduce transfusion in major non-cardiac surgery (TRACTION): A pragmatic randomized cluster crossover trial
Quality Improvement & Outcomes
Tranexamic acid (TXA) is an inexpensive drug that can reduce the need for blood transfusion in cardiac and orthopedic surgery (where TXA is standard of care). Despite explanatory trials supporting TXA’s role in reducing transfusion without evidence of increased thrombotic risk in major non-cardiac surgery, TXA use is variable in these other high risk of bleeding surgeries. By using a pragmatic, policy-evaluation design we will address the identified barrier to more widespread TXA use. If TXA is effective and safe, we will be able to save health care resources in Ontario by improving outcomes and decreasing transfusion rates for patients undergoing major non-cardiac surgery.
Objectives: To examine whether hospital-level implementation of routine Tranexamic Acid (TXA) use in patients undergoing major non-cardiac surgery will reduce red blood cell (RBC) transfusion without increasing thrombotic risk.
Methodology: The TRACTION Trial is a pragmatic, multicenter, randomized, registry-based cluster-crossover trial. Patients aged 18 years and over with Increased local fibrinolysis undergoing surgeries known to have a baseline transfusion rate of 5% or greater are enrolled into the trial. Each institution is randomized to either TXA (1 gram intravenous bolus followed by 1 additional gram prior to skin closure) or placebo, used as standard policy for the one-month period, after which sites are re-randomized. Intervention assignment is only known to the research pharmacy staff who prepare the study drug. Outcome data will be collected through medical chart review and existing provincial electronic databases.
Results/Outcomes: There are 10 active sites (7 in Ontario; 3 in Manitoba). As of end of August 2023, the trial had reached 62% enrollment (5,250 of 8,320). Co-primary outcomes include: a) the proportion of patients transfused red blood cells; and b) the incidence of deep vein thrombosis or pulmonary embolus within 3 months of surgery.
Conclusions: The trial is on target to complete recruitment by December 2023. If hospital-level TXA is proven to be effective and safe, we will be able to save Ontario health care resources by improving outcomes and decreasing transfusion rates for patients undergoing major non-cardiac surgery.
Next steps: At the completion of the trial, we will work with our patient-partners, decision-, and policy-makers to craft individualized knowledge translation strategies so the results of the study effectively impacts perioperative surgical policy in participating hospitals in Ontario, across Canada and the world.
Not yet applicable.