Overview

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

Status:
Recruiting
Trial end date:
2027-08-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborator:
HepatoPancreaticoBiliary (HPB) Concept Team
Treatments:
Tranexamic Acid