Infusion

Grand Rounds September 11, 2026: Embedded Trials in a Learning Health System: A Hospital Policy of Tranexamic Acid to Reduce Transfusion in Major Noncardiac Surgery (Ryan Zarychanski, MD, MSc, FRCPC, FCAHS)

Posted on by Sophia Ramirez

Speaker

Ryan Zarychanski, MD, MSc, FRCPC, FCAHS
Professor of Medicine (Hematology and Critical Care), Pharmacy, and Community Health Sciences
Tier 1 Canada Research Chair in Clinical Trials
Max Rady College of Medicine | University of Manitoba
Hematologist and Senior Scientist
CancerCare Manitoba and Research Institute
Scientific Director
George and Fay Yee Centre for Healthcare Innovation & Aurora Clinical Research

Keywords

Infusion; Surgery; Tranexamic Acid; Noncardiac Surgery

Key Points

  • Tranexamic acid (TXA) is an inexpensive, widely available resource with an established safety profile. Evidence shows that the use of TXA during cardiac surgeries reduces the rate of blood transfusion – an expensive procedure involving a limited resource.
  • The TRACTION trial sought to assess the use of TXA in non-cardiac surgery through a multicenter randomized controlled trial with 2 co-primary outcomes: the proportion of patients who received a blood transfusion and the rate of venous thromboembolism (VTE) within 90 days of the surgery.
  • Patients undergoing surgeries with over 5% risk of transfusion were eligible. Ultimately, 8,400 patients were enrolled across 10 sites in Canada. The study team utilized a cluster-randomized embedded design; each site was randomized to either placebo or TXA every 4 weeks.
  • TXA reduced the rate of transfusion during non-cardiac surgeries, with 7.4% of patients in the intervention arm versus 9.8% in the control arm. Thrombotic event rates were equivalent between the 2 groups. Novel methods like the cluster-randomized embedded design, risk-adapted consent, and electronic data capture increased efficiency and substantially reduced the cost of the trial.

Discussion Themes

Years of preparatory studies, statistical modeling, and navigating complex provincial and governmental data-sharing agreements were required before trial launch.

A decision not to include pregnant women in the trial was driven by hospital leadership's risk aversion and liability concerns rather than regulatory or IRB refusals.

A strict 1% non-inferiority margin for thrombotic safety was established through direct consultation with patient groups and clinicians.