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

NCT02261415 · tracked via the Priya Life Science Canada tracker

Sponsor

Sunnybrook Health Sciences Centre

Phase

Phase 3

Started

2014-11

Last updated

2022-10-26

Condition(s) studied

CancerTumourSurgery

Investigational drug(s) / intervention(s)

Tranexamic acid (TXA) →Normal saline

Tranexamic acid (TXA): 1 g TXA bolus injection + 1 g TXA infusion from induction over 8 hours

Normal saline: 1 g saline bolus injection + 1 g saline infusion from induction over 8 hours

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Receipt of blood transfusion (% transfused): 7 days — 7 days
Receipt of one or more RBC transfusions between Day 0 and Day 7

Trial sites (11)

Facility	City	Region
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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02261415 on ClinicalTrials.gov ↗ ← All trials in Canada