The HeLiX (Hemorrhage During Liver Resection: traneXamic Acid) Trial

Summary

This is a Phase III multicentre randomized controlled trial (RCT) to evaluate the impact of tranexamic acid (TXA) on perioperative blood transfusion in patients undergoing liver resection. The rationale for this study includes: (1) experimental evidence supporting the use of TXA in other surgical populations; (2) lack of evidence in patients undergoing liver resection; (3) clinical uncertainty and extensive support amongst hepatobiliary surgeons, anaesthesiologists, and hematologists for this proposed trial; (4) a feasible and efficient study design; and (5) the importance of the question: incidence of blood transfusion in patients undergoing liver resection is high, and the consequences serious. The sample size for this study is 1230 participants.Participants enrolled in the prior Vanguard study will proceed directly into the RCT.

Timeline

Start

2014-11

Primary completion

2022-08

Completion

2027-08

Publications

• Karanicolas PJ, Lin Y, McCluskey SA, Tarshis J, Thorpe KE, Wei A, Dixon E, Porter G, Chaudhury P, Nanji S, Ruo L, Tsang ME, Skaro A, Eeson G, Cleary S, Moulton CA, Ball CG, Hallet J, Coburn N, Serrano PE, Jayaraman S, Law C, Tandan V, Sapisochin G, Nagorney D, Quan D, Smoot R, Gallinger S, Metrakos P, Reichman TW, Jalink D, Bennett S, Sutherland F, Solano E, Molinari M, Tang ES, Warner SG, Bathe OF, Barkun J, Kendrick ML, Truty M, Roke R, Xu G, Lafreniere-Roula M, Guyatt G; HPB CONCEPT Team. Tranexamic Acid in Patients Undergoing Liver Resection: The HeLiX Randomized Clinical Trial. JAMA. 2024 Oct 1;332(13):1080-1089. doi: 10.1001/jama.2024.11783.
• Karanicolas PJ, Lin Y, McCluskey S, Roke R, Tarshis J, Thorpe KE, Ball CG, Chaudhury P, Cleary SP, Dixon E, Eeson G, Moulton CA, Nanji S, Porter G, Ruo L, Skaro AI, Tsang M, Wei AC, Guyatt G; HepatoPancreaticoBiliary Community of Surgical ONcologists: Clinical, Evaluative, and Prospective Trials (HPB CONCEPT) Team. Tranexamic acid versus placebo to reduce perioperative blood transfusion in patients undergoing liver resection: protocol for the haemorrhage during liver resection tranexamic acid (HeLiX) randomised controlled trial. BMJ Open. 2022 Feb 24;12(2):e058850. doi: 10.1136/bmjopen-2021-058850.

Drugs

Indications