The HeLiX (Hemorrhage During Liver Resection: traneXamic Acid) Trial (NCT02261415)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (12 items).
Location: Mayo Clinic — Rochester, Minnesota
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (11 Sites)
- Mayo Clinic — Rochester, Minnesota
- Foothills Hospital — Calgary, Alberta
- Kelowna General Hospital — Kelowna, British Colombia
- Queen Elizabeth II Health Sciences Centre — Halifax, Nova Scotia
- Hamilton Health Sciences — Hamilton, Ontario
- Kingston General Health Research Institute — Kingston, Ontario
- London Health Sciences Centre — London, Ontario
- Sunnybrook Health Sciences Centre — Toronto, Ontario
- University Health Network — Toronto, Ontario
- St. Joseph's Health Centre — Toronto, Ontario
- McGill University Health Centre — Montreal, Quebec
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.