Hospital Policy of Tranexamic Acid to Reduce Transfusion in Major Non-cardiac Surgery (TRACTION): Protocol for a Phase IV Randomised Controlled Trial
Abstract
Tranexamic acid (TXA) is a widely available and affordable medication that reduces blood loss and red blood cell (RBC) transfusion in cardiac and orthopaedic surgeries. This trial aims to evaluate whether implementing a hospital-level policy of routine TXA use in major non-cardiac surgeries decreases RBC transfusion without increasing thrombotic risk.
Methods and Analysis
A pragmatic, blinded, cluster-crossover randomised controlled trial at 10 Canadian sites will assess the impact of intraoperative TXA administration in patients undergoing non-cardiac surgeries at high risk for RBC transfusion. The primary outcomes are the proportion of patients transfused RBCs during hospital admission and the proportion of patients diagnosed with venous thromboembolism within 90 days.
Ethics and Dissemination
The trial has received approval from institutional research ethics boards at all sites. Plain language summaries of the results will be published on the trial website and distributed in the lay press. The trial results will also be submitted for publication in a peer-reviewed scientific journal.
Trial Registration Number
NCT04803747
