TXA for Bleeding in Liver Surgery

(HeLiX Trial)

Recruiting at 11 trial locations

Overseen by Paul Karanicolas, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Sunnybrook Health Sciences Centre

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Paul Karanicolas, MD, PhD

Principal Investigator

Sunnybrook Health Sciences Centre

Eligibility Criteria

This trial is for adults over 18 who have a cancer diagnosis or suspicion and are scheduled for liver surgery. It's not for those with recent thrombosis, severe kidney issues, seizure disorders, color vision problems, trouble receiving blood products, on certain anticoagulants or thrombolytic therapy within the last week, previously in this study, severely anemic individuals, or pregnant/lactating women.

Inclusion Criteria

I have been diagnosed with a cancer-related condition.

I am scheduled for liver surgery, either open or with a camera.

I am 18 years old or older.

Exclusion Criteria

You are allergic to TXA or any of the ingredients in it.

I haven't taken any blood thinners, except for low doses to prevent clots, in the last week.

I have a history of seizures.

Treatment Details

Interventions

• Tranexamic acid (TXA) (Anti-fibrinolytic agent)

Trial Overview The HeLiX Trial is testing whether tranexamic acid (TXA) can reduce the need for blood transfusions during liver resection surgeries compared to normal saline. This Phase III trial involves randomly assigning participants to either TXA or saline groups across multiple centers.

Participant Groups

Group I: Tranexamic acid (TXA) Experimental Treatment 1 Intervention

1 g TXA bolus injection + 1 g TXA infusion from induction over 8 hours

Group II: Normal saline (0.9% sodium chloride) Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

HepatoPancreaticoBiliary (HPB) Concept Team

Collaborator

Trials

1

Recruited

1,400+