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

Running, not enrolling · Phase 3

Conditions studied: Cancer, Tumour, Surgery

In brief

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.

Key facts

Study ID

NCT02261415

Run by

Sunnybrook Health Sciences Centre

People needed

1386

Starts

2014-11-01

Expected to finish

2027-08-01

Last updated by the study team

2022-10-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States
• Foothills Hospital — Calgary, Alberta, Canada
• Kelowna General Hospital — Kelowna, British Colombia, Canada
• Queen Elizabeth II Health Sciences Centre — Halifax, Nova Scotia, Canada
• Hamilton Health Sciences — Hamilton, Ontario, Canada
• Kingston General Health Research Institute — Kingston, Ontario, Canada
• London Health Sciences Centre — London, Ontario, Canada
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
• University Health Network — Toronto, Ontario, Canada
• St. Joseph's Health Centre — Toronto, Ontario, Canada
• McGill University Health Centre — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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