Clinical Trial

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

Study acronym: HeLiX
Active, Not Recruiting Phase 3
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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.
Protocol Amendment History 18 amendments
This ClinicalTrials.gov record has been amended 18 times since 2014-10-07; most recent amendment 2022-10-25.
Status change: Recruiting → Active, Not Recruiting 2022-10-25
Status change: Active, Not Recruiting → Recruiting 2016-02-08
Status change: Recruiting → Active, Not Recruiting 2015-12-03
Status change: Not Yet Recruiting → Recruiting 2014-11-17
Trial Details
NCT Number NCT02261415
Lead Sponsor Sunnybrook Health Sciences Centre
Collaborators: HepatoPancreaticoBiliary (HPB) Concept Team
Conditions Cancer, Tumour, Surgery
Enrollment 1,386 participants
Start Date 2014-11
Primary Completion 2022-08 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2022-10-26