Original Investigation 

August 19, 2024

Tranexamic Acid in Patients Undergoing Liver Resection: The HeLiX Randomized Clinical Trial

Paul J. Karanicolas, Yulia Lin, Stuart A. McCluskey, et al

JAMA. Published online August 19, 2024. doi:10.1001/jama.2024.11783

Key Points

Question  Does tranexamic acid reduce red blood cell transfusion within 7 days of liver resection?

Findings  In this randomized clinical trial, red blood cell transfusion within 7 days of surgery occurred in 16.3% of participants receiving tranexamic acid and 14.5% receiving placebo. Participants receiving tranexamic acid experienced significantly more complications perioperatively compared with placebo (odds ratio, 1.28; 95% CI, 1.02-1.60; P = .03).

Meaning  Among patients undergoing liver resection for a cancer-related indication, tranexamic acid did not reduce bleeding or blood transfusion but increased perioperative complications.

Abstract

Importance  Tranexamic acid reduces bleeding and blood transfusion in many types of surgery, but its effect in patients undergoing liver resection for a cancer-related indication remains unclear.

Objective  To determine whether tranexamic acid reduces red blood cell transfusion within 7 days of liver resection.

Design, Setting, and Participants  Multicenter randomized clinical trial of tranexamic acid vs placebo conducted from December 1, 2014, to November 8, 2022, at 10 hepatopancreaticobiliary sites in Canada and 1 site in the United States, with 90-day follow-up. Participants, clinicians, and data collectors were blinded to allocation. A volunteer sample of 1384 patients undergoing liver resection for a cancer-related indication met eligibility criteria and consented to randomization.

Interventions  Tranexamic acid (1-g bolus followed by 1-g infusion over 8 hours; n = 619) or matching placebo (n = 626) beginning at induction of anesthesia.

Main Outcomes and Measures  The primary outcome was receipt of red blood cell transfusion within 7 days of surgery.

Results  The primary analysis included 1245 participants (mean age, 63.2 years; 39.8% female; 56.1% with a diagnosis of colorectal liver metastases). Perioperative characteristics were similar between groups. Red blood cell transfusion occurred in 16.3% of participants (n = 101) in the tranexamic acid group and 14.5% (n = 91) in the placebo group (odds ratio, 1.15 [95% CI, 0.84-1.56]; P = .38; absolute difference, 2% [95% CI, −2% to 6%]). Measured intraoperative blood loss (tranexamic acid, 817.3 mL; placebo, 836.7 mL; P = .75) and total estimated blood loss over 7 days (tranexamic acid, 1504.0 mL; placebo, 1551.2 mL; P = .38) were similar between groups. Participants receiving tranexamic acid experienced significantly more complications compared with placebo (odds ratio, 1.28 [95% CI, 1.02-1.60]; P = .03), with no significant difference in venous thromboembolism (odds ratio, 1.68 [95% CI, 0.95-3.07]; P = .08).

Conclusions and Relevance  Among patients undergoing liver resection for a cancer-related indication, tranexamic acid did not reduce bleeding or blood transfusion but increased perioperative complications.

Trial Registration  ClinicalTrials.gov Identifier: NCT02261415