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Anti-fibrinolytic agent

TXA for Bleeding in Liver Surgery (HeLiX Trial)

Phase 3
Waitlist Available
Led By Paul Karanicolas, MD PhD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cancer related diagnosis or indication (e.g. pre-cancer, suspicion of cancer, definite cancer)
Patient scheduled for open or laparoscopic liver surgery
Must not have
History of seizure disorder
Known disseminated intravascular coagulation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
Pivotal Trial

Summary

This trial will evaluate the impact of tranexamic acid on perioperative blood transfusion in patients undergoing liver resection. TXA is given to help prevent or treat excessive bleeding. The study will enroll 1230 participants.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Tranexamic acid may cause side effects such as nausea and diarrhea. In rare cases it could increase the risk of clots forming in your veins (thrombosis). Normal saline typically has fewer side effects but might include mild reactions at the infusion site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a cancer-related condition.
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I am scheduled for liver surgery, either open or with a camera.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of seizures.
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I have a condition that affects my blood's ability to clot.
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My kidneys are not working well (low creatinine clearance).
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I cannot receive blood products due to past severe reactions or personal reasons.
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I have recently developed problems with seeing colors.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Receipt of blood transfusion (% transfused): 7 days
Secondary study objectives
Compare the cost of tranexamic acid (TXA) versus placebo on perioperative blood transfusion in patients undergoing liver resection
Intraoperative blood loss
Number of packed red blood cells (PRBC) units transfused
+8 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Tranexamic acid (TXA)Experimental Treatment1 Intervention
1 g TXA bolus injection + 1 g TXA infusion from induction over 8 hours
Group II: Normal saline (0.9% sodium chloride)Placebo Group1 Intervention
1 g saline bolus injection + 1 g saline infusion from induction over 8 hours
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic acid (TXA)
2013
Completed Phase 4
~280

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
680 Previous Clinical Trials
1,564,480 Total Patients Enrolled
HepatoPancreaticoBiliary (HPB) Concept TeamUNKNOWN
Paul Karanicolas, MD PhDPrincipal InvestigatorSunnybrook Health Sciences Centre
5 Previous Clinical Trials
2,909 Total Patients Enrolled

Media Library

Tranexamic acid (TXA) (Anti-fibrinolytic agent) Clinical Trial Eligibility Overview. Trial Name: NCT02261415 — Phase 3
Cancer Research Study Groups: Tranexamic acid (TXA), Normal saline (0.9% sodium chloride)
Cancer Clinical Trial 2023: Tranexamic acid (TXA) Highlights & Side Effects. Trial Name: NCT02261415 — Phase 3
Tranexamic acid (TXA) (Anti-fibrinolytic agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02261415 — Phase 3
~125 spots leftby Dec 2025
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