TRACTION Trial Shows Tranexamic Acid Reduces Blood Transfusions by 31% in Non-Cardiac Surgery Without Increasing Clot Risk
核心洞察
The TRACTION trial demonstrated that tranexamic acid reduced the need for red blood cell transfusions by 31% in patients undergoing high-risk non-cardiac surgeries compared to placebo.
Among 8,273 patients across 10 Canadian hospitals, tranexamic acid lowered transfusion rates from 9.8% to 7.4% without increasing venous thromboembolism (搜索) risk.
The findings suggest broad implementation could prevent 5-10 million units of perioperative red cell transfusions annually in the estimated 100 million non-cardiac surgeries performed yearly.
A large-scale randomized trial has demonstrated that tranexamic acid, an inexpensive medication available for over 50 years, can significantly reduce the need for blood transfusions during non-cardiac surgeries without increasing the risk of dangerous blood clots. The findings, presented at the 67th American Society of Hematology (搜索) Annual Meeting in Orlando, could have major implications for healthcare systems facing ongoing blood supply shortages.
Major Reduction in Transfusion Requirements
The TRACTION trial, conducted across 10 hospitals in Canada from February 2022 to 2024, enrolled 8,273 patients undergoing major non-cardiac surgeries. Researchers found that patients treated at hospitals implementing a tranexamic acid policy had a 31% lower likelihood of requiring blood transfusions compared to those receiving placebo.
"The proportion of patients who required transfused red blood cells during hospital admission was 7.4% in the tranexamic acid arm and 9.8% in the placebo arm, which equates to a 2.4% absolute risk reduction," said Brett Houston, M.D., Ph.D., assistant professor at the University of Manitoba and lead investigator.
The tranexamic acid group also received significantly fewer red blood cell units overall, with a mean of 0.34 units compared to 2.5 units in the placebo group.
Safety Profile Maintained Across High-Risk Populations
A critical finding was that tranexamic acid did not increase the risk of venous thromboembolism (搜索), with rates remaining identical at 2.1% in both treatment arms. This safety profile held even among cancer (搜索) patients, who comprised 60.5% of the study population and face particularly elevated thrombosis risk.
"Tranexamic acid, importantly, did not increase venous thromboembolism (搜索) or blood clots, even among patients with cancer (搜索) who had particularly increased risk," Houston emphasized during a press briefing.
The study found no significant differences between groups in hospital diagnoses of myocardial infarction (搜索), stroke (搜索), deep vein thrombosis (搜索), or pulmonary embolism (搜索). Similarly, there were no differences in ICU admission rates, hospital length of stay, hospital survival, or overall survival at 90 days.
Addressing Critical Blood Supply Challenges
The findings come at a time when blood supply shortages continue to challenge healthcare systems. According to the American Red Cross, 21 million blood components are transfused annually in the United States, and officials declared an emergency blood shortage last year.
Houston highlighted the potential population-level impact: "If there are approximately 100 million inpatient noncardiac surgeries each year, administering this medication broadly has the potential to reduce exposure to perioperative red blood cell transfusions in 1 million to 2 million people each year. Further, it could potentially mitigate 5 million to 10 million units of perioperative red cell transfusions."
Innovative Trial Design Enables Cost-Effective Research
The TRACTION trial employed a multicenter, randomized, placebo-controlled cluster crossover design, with hospitals randomly allocated to provide tranexamic acid or placebo to patients undergoing high-risk non-cardiac surgery in four-week intervals.
Eligible patients included adults undergoing major non-cardiac surgeries, including both open and laparoscopic procedures lasting three or more hours. Tranexamic acid was administered as a one-gram bolus at surgery start, followed by an additional one gram prior to skin closure at the treating anesthesiologist's discretion.
"The novel methods used in TRACTION — a cluster, crossover design with limited manual data capture and an electronic registry — enabled us to conduct the trial at a fraction of the cost that it would typically take using traditional methods," Houston noted. "We've demonstrated that large, high-quality, practice-changing, and cost-effective trials can be conducted using routinely collected data."
Established Drug with Expanding Applications
Tranexamic acid has been available for more than 50 years and is currently approved only for heavy menstrual bleeding and short-term prevention in patients with hemophilia (搜索). However, it has been used off-label in trauma situations and some surgeries, with established efficacy in cardiac surgery, orthopedic surgery, trauma, and postpartum hemorrhage.
"Tranexamic acid is inexpensive, widely available, and has an established side effect profile," Houston said. "Prior trials have evaluated tranexamic acid in the context of noncardiac surgery, although uptake has been somewhat limited due to residual concerns of thrombosis."
The researchers plan to disseminate these results widely to support routine integration of tranexamic acid into clinical practice for non-cardiac surgeries, potentially establishing it as a standard hospital policy similar to prophylactic antibiotic administration.