Tranexamic acid or TXA (Cyklokapron®; Pfizer) is an inexpensive and widely available generic drug that promotes blood clotting, which is essential to stop blood loss from injuries or during surgery. In cardiac and orthopedic surgeries, tranexamic acid is routinely used to reduce red blood cell (RBC) transfusion. Although the use of tranexamic acid in these surgeries is routine, its efficacy and safety in other, non-cardiac and non-orthopedic surgeries, with comparable rates of transfusion have, so-far, been unknown.
A study funded by the Canadian Institutes of Health Research, the Health Sciences Centre Foundation of Manitoba, and the health ministries of the Canadian provinces of Manitoba and Ontario suggest that when hospitals were randomly assigned to treat patients undergoing higher-risk non-cardiac surgery with tranexamic acid (TXA) or a placebo, patients who received tranexamic acid needed significantly fewer blood transfusions and saw no increase in potentially life-threatening blood clots (thrombosis) after 90 days of follow-up.[1][2]
The results of the study were presented at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, held December 6 – 9, 2025 in Orlando, Florida.[3]
“Our findings confirm that tranexamic acid reduces the need for blood transfusion in patients undergoing higher-risk non-cardiac surgery,” explained lead study author Brett Houston, MD, PhD, an assistant professor at the University of Manitoba and a scientist with the Paul Albrechtsen Research Institute in Winnipeg, Canada.
“We were also able to show that giving tranexamic acid is safe and does not increase the occurrence of dangerous blood clots within the three-month high-risk period after surgery.”
Life-threatening complications
A 2019 international study of 40,000 patients found major bleeding to be the most common life-threatening complication following non-cardiac surgery. Another large international randomized trial, known as POISE-3 (NCT03505723) demonstrated that, compared with patients who received a placebo, patients who received tranexamic acid immediately before and after non-cardiac surgery had significantly less serious bleeding and needed fewer blood transfusions, with no significant increase in heart attacks, strokes, or blood clots at 30 days.[4][5]
The current study, known as TRACTION (NCT04803747), was designed to build on the findings of POISE-3, Houston said. Participating hospitals – 10 medical centers in Canada – were randomly assigned to administer either tranexamic acid or a placebo to adult patients undergoing major non-cardiac surgical procedures that posed an elevated risk for post-surgical bleeding complications and blood clots. Every four weeks, hospitals in the tranexamic acid group switched to the placebo group and vice versa.
Study participants either received a first dose of tranexamic acid or the placebo intravenously within minutes of surgery initiation. At the discretion of the attending anesthesiologist, they then received a second dose either at the conclusion of the operation or as a continuous infusion throughout the procedure.
Endpoints
The study’s primary endpoints were the number of patients needing blood transfusions during their hospital stay and the number diagnosed with blood clots within 90 days.
Secondary endpoints included the number of units of blood transfused; the number of patients diagnosed with a heart attack, stroke, or blood clot while in the hospital; the number of patients admitted to intensive care; the number surviving at 90 days after surgery; and patients’ length of stay in the hospital.
The study’s results are based on the evaluation of 8,273 patients treated across the 10 participating hospitals. More than 60% of the patients underwent cancer surgery. Among patients treated with tranexamic acid, 7.4% received a blood transfusion while in the hospital compared with 9.8% of those treated with the placebo, a statistically significant difference. Patients treated with tranexamic acid needed significantly fewer units of blood (0.34 units on average) than those in the placebo group (2.5 units on average). The proportion of patients diagnosed with blood clots within 90 days was the same (2.1%) in both the tranexamic acid and placebo groups. No significant differences were seen in any of the secondary endpoints.
“The finding that tranexamic acid use does not increase risk for blood clots during the 90-day post-surgical period of elevated risk may reassure many practitioners who have previously been hesitant to adopt the drug,” Houston said.
“We hope this data will also set practitioners’ minds at rest that giving the drug is safe,” she said.
Study limitation
Although the study was limited to Canada, it evaluated bleeding risk across a broad range of types of higher-risk non-cardiac surgery, including gynecologic, urologic, spinal, blood-vessel, and cancer surgery. In addition, participating hospitals included both academic medical centers and community hospitals.
Further, a limitation of the study is that participation was restricted to hospitals with sophisticated electronic medical records systems in place to transmit study data.
“Findings from other studies suggest that the use of TXA could be successfully introduced as a hospital-level policy in the same way that other surgical safety practices, such as antibiotic administration to prevent infection and the use of surgical checklists have been adopted,” Houston said.
As a next step, Houston and her colleagues plan to work on educating physicians about the TRACTION findings and promoting the adoption of tranexamic acid administration as a standard practice during higher-risk non-cardiac surgery.
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Clinical trials
PeriOperative ISchemic Evaluation-3 Trial (POISE-3) – ClinicalTrials.gov ID NCT03505723
A Trial of a Hospital Policy of Tranexamic Acid Use to Reduce Transfusion in Major Non-cardiac Surgery (TRACTION) – ClinicalTrials.gov ID NCT04803747
Highlights of prescribing information
Tranexamic acid (Cyklokapron®; Pfizer)[Prescribing Information]
Reference
[1] Ng W, Jerath A, Wąsowicz M. Tranexamic acid: a clinical review. Anaesthesiol Intensive Ther. 2015;47(4):339-50. doi: 10.5603/AIT.a2015.0011. Epub 2015 Mar 23. PMID: 25797505.
[2] Houston BL, McIsaac DI, Breau RH, Andrews M, Avramescu S, Bagry H, Balshaw RF, Daya J, Duncan K, Harle C, Jacobsohn E, Kerelska T, McIsaac S, Ramsay T, Saha T, Perelman I, Recio A, Solvason D, Szoke D, Tenenbein M, Fergusson DA, Zarychanski R. Hospital policy of tranexamic acid to reduce transfusion in major non-cardiac surgery (TRACTION): protocol for a phase IV randomised controlled trial. BMJ Open. 2024 Jun 3;14(6):e084847. doi: 10.1136/bmjopen-2024-084847. PMID: 38830735; PMCID: PMC11149158.
[3] Houston B, McIsaac D, Breau R, Greenstreet P, Andrews M, Avramescu S, Bagry H, Balshaw R, Daya J, Duncan K, Harle C, Jacobsohn E, Kerelska T, Pitz M, Komenda P, McIsaac S, Ramsay T, Saha T, Tinmouth A, Recio A, Solvason D, Szoke D, Tenenbein M, Talarico R, Fergusson D, Zarychanski R. A hospital policy of tranexamic acid to reduce transfusion in major non-cardiac surgery: The traction trial (ASH Publication Number: LBA-5)[Abstract] [Full Abstract] 67th ASH® Annual Meeting, December 6 – 9, 2025, Orlando, Florida.
[4] Vascular Events in Noncardiac Surgery Patients Cohort Evaluation (VISION) Study Investigators; Spence J, LeManach Y, Chan MTV, Wang CY, Sigamani A, Xavier D, Pearse R, Alonso-Coello P, Garutti I, Srinathan SK, Duceppe E, Walsh M, Borges FK, Malaga G, Abraham V, Faruqui A, Berwanger O, Biccard BM, Villar JC, Sessler DI, Kurz A, Chow CK, Polanczyk CA, Szczeklik W, Ackland G, X GA, Jacka M, Guyatt GH, Sapsford RJ, Williams C, Cortes OL, Coriat P, Patel A, Tiboni M, Belley-Côté EP, Yang S, Heels-Ansdell D, McGillion M, Parlow S, Patel M, Pettit S, Yusuf S, Devereaux PJ. Association between complications and death within 30 days after noncardiac surgery. CMAJ. 2019 Jul 29;191(30):E830-E837. doi: 10.1503/cmaj.190221. PMID: 31358597; PMCID: PMC6663503.
[5] Devereaux PJ, Marcucci M, Painter TW, Conen D, Lomivorotov V, Sessler DI, Chan MTV, Borges FK, Martínez-Zapata MJ, Wang CY, Xavier D, Ofori SN, Wang MK, Efremov S, Landoni G, Kleinlugtenbelt YV, Szczeklik W, Schmartz D, Garg AX, Short TG, Wittmann M, Meyhoff CS, Amir M, Torres D, Patel A, Duceppe E, Ruetzler K, Parlow JL, Tandon V, Fleischmann E, Polanczyk CA, Lamy A, Astrakov SV, Rao M, Wu WKK, Bhatt K, de Nadal M, Likhvantsev VV, Paniagua P, Aguado HJ, Whitlock RP, McGillion MH, Prystajecky M, Vincent J, Eikelboom J, Copland I, Balasubramanian K, Turan A, Bangdiwala SI, Stillo D, Gross PL, Cafaro T, Alfonsi P, Roshanov PS, Belley-Côté EP, Spence J, Richards T, VanHelder T, McIntyre W, Guyatt G, Yusuf S, Leslie K; POISE-3 Investigators. Tranexamic Acid in Patients Undergoing Noncardiac Surgery. N Engl J Med. 2022 May 26;386(21):1986-1997. doi: 10.1056/NEJMoa2201171. Epub 2022 Apr 2. PMID: 35363452.
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DOI
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