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

• Status: Recruiting
• Trial end date: 2027-08-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunnybrook Health Sciences Centre
• Collaborator: HepatoPancreaticoBiliary (HPB) Concept Team
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• Patient scheduled for open or laparoscopic liver surgery

• Age ≥18 years

• Cancer related diagnosis or indication (e.g. pre-cancer, suspicion of cancer, definite cancer)

Exclusion Criteria:

• Severe anemia (hemoglobin (Hgb) levels <90 g/l)

• Documented arterial or venous thrombosis at screening or in past three months (not including therapeutic portal vein embolization)

• Anticoagulants (other than low-molecular-weight heparin (LMWH) or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week

• Known disseminated intravascular coagulation

• Severe renal insufficiency (creatinine clearance (CrCl) <30 ml/min)

• History of seizure disorder

• Pregnant or lactating (a negative urine pregnancy test must be obtained for women of child bearing potential during the pretreatment evaluation)

• Acquired disturbance of colour vision

• Hypersensitivity to TXA or any of the ingredients

• Unable to receive blood products (i.e. difficulty with cross matching, refuses blood transfusion, or a past history of unexplained severe transfusion reaction)

• Previously enrolled in this study