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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights

HeLiX 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.Check my eligibility
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.See study design
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.

HeLiX Trial 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.

HeLiX Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Receipt of blood transfusion (% transfused): 7 days
Secondary outcome measures
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

HeLiX 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
651 Previous Clinical Trials
1,541,303 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people enrolling in this experiment right now?

"Unfortunately, this particular study has stopped recruiting patients. The trial was first announced on November 1st, 2014 but was last updated on October 25th, 2022. However, there are presently 1140 trials actively admitting patients with malignancies and 175 trials for Tranexamic acid (TXA) actively enrolling patients."

Answered by AI

Does Tranexamic acid (TXA) have any negative side effects for patients?

"While Phase 3 trials are not the final stage of testing, they are critical in that they provide efficacy data as well as multiple rounds of data supporting safety. Based on this, our team at Power has rated Tranexamic acid (TXA) as a 3 in terms of safety."

Answered by AI

How many different places are coordinating this clinical trial?

"Patients are being accepted at several institutions across North America, including but not limited to McGill University Health Centre in Montreal, Quebec, Sunnybrook Health Sciences Centre in Toronto, Alberta, and Kingston General Health Research Institute in Kingston, Minnesota."

Answered by AI

What are some of the most common reasons that Tranexamic acid (TXA) is given to patients?

"While most commonly used to treat diarrhea, Tranexamic acid (TXA) can also be employed in the treatment of general surgery, urine alkalinization therapy, and sodium depletion."

Answered by AI

Could you please provide an overview of other research projects that have used Tranexamic acid (TXA)?

"At the moment, 175 clinical trials are underway to research Tranexamic acid (TXA). Out of these, 57 are in Phase 3. Calgary, Alberta has a high concentration of these trials, with 57 total, but Tranexamic acid (TXA) trials are happening in 665 locations worldwide."

Answered by AI

How many people suffering from this disease have been given the chance to try this treatment?

"Unfortunately, this trial is not currently recruiting patients. Although, it's worth noting that the trial was last updated on 10/25/2022. If you're interested in other studies, there are 1140 clinical trials for cancer patients and 175 trials for Tranexamic acid (TXA) that are presently active."

Answered by AI
~134 spots leftby Mar 2025