TXA for Bleeding in Liver Surgery

(HeLiX Trial)

Not currently recruiting at 11 trial locations

Overseen By Nicole Cooke

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Sunnybrook Health Sciences Centre

Must not be taking: Anticoagulants, Thrombin inhibitors

Disqualifiers: Severe anemia, Thrombosis, Renal insufficiency, Seizure disorder, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Immediate perioperative period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if tranexamic acid (TXA) can reduce the need for blood transfusions during liver surgery. Blood transfusions are common and can lead to serious complications, so reducing them is crucial. Participants will receive either TXA or a placebo (a harmless substance with no treatment effect) to compare outcomes. Those scheduled for liver surgery due to cancer, without severe anemia or recent blood clots, might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications, but you cannot participate if you've taken certain blood thinners or clot-busting drugs in the past week.

Is there any evidence suggesting that tranexamic acid (TXA) is likely to be safe for humans?

Studies have shown that tranexamic acid (TXA) can reduce the need for blood transfusions during surgeries. However, its effects in liver surgeries remain unclear. Some research suggests that TXA does not lower the risk of bleeding or death in these operations and may increase the risk of blood clots.

In other types of surgeries, TXA is generally well-tolerated. The trial's advanced stage indicates that TXA has demonstrated a good safety record in earlier tests. However, in liver surgeries, the risk of blood clots might be higher. Participants should consider this when deciding whether to join the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for bleeding during liver surgery, which often rely on blood transfusions and other supportive measures, tranexamic acid (TXA) offers a unique approach by directly targeting the body's natural clot-dissolving process. TXA works by inhibiting fibrinolysis, the process that breaks down blood clots, thereby helping to reduce excessive bleeding. Researchers are excited about TXA because it has the potential to minimize blood loss more effectively and safely, possibly reducing the need for blood transfusions and their associated risks. This could lead to quicker recoveries and fewer complications for patients undergoing liver surgery.

What evidence suggests that tranexamic acid (TXA) might be an effective treatment for bleeding in liver surgery?

This trial will compare the effects of tranexamic acid (TXA) with a placebo in liver surgery. Studies have shown that TXA effectively reduces bleeding during surgery. Large trials found that TXA significantly decreased the need for blood transfusions in liver surgery patients. However, some research suggests that while TXA might help with bleeding, it could also increase the risk of blood clots. In liver surgeries, TXA has lowered the rate of blood transfusions and improved outcomes related to bleeding. Overall, TXA shows promise in reducing surgical bleeding, but potential risks require careful consideration. ^{1 3 4 6 7}

Who Is on the Research Team?

Paul Karanicolas, MD, PhD

Principal Investigator

Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either tranexamic acid (TXA) or placebo during liver resection surgery

Immediate perioperative period

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for blood transfusion needs and complications for 7 days post-surgery

7 days

Follow-up

Participants are monitored for long-term outcomes including survival and recurrence every 6 months

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Tranexamic acid (TXA)

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

Tranexamic acid (TXA) was successfully used to achieve hemostasis in a 72-year-old male patient on rivaroxaban, who experienced persistent bleeding after a biopsy, demonstrating its potential effectiveness in patients on direct oral anticoagulants (DOACs).

The intervention was simple, cost-effective, and required minimal resources, providing a novel approach to manage uncontrollable bleeding in anticoagulated patients when traditional methods were ineffective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical Tranexamic Acid for Hemostasis of an Oral Bleed in a Patient on a Direct Oral Anticoagulant. Boccio, E., Hultz, K., Wong, AH.[2022]

A systematic review and meta-analysis of four studies involving 2,347 trauma patients showed that prehospital administration of tranexamic acid (TXA) significantly reduces early mortality (within 24 hours) compared to no TXA, with an odds ratio of 0.60.

The use of TXA did not increase the risk of venous thromboembolism, indicating it is a safe intervention for managing bleeding in trauma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of prehospital TXA on mortality among bleeding trauma patients: A systematic review and meta-analysis. Almuwallad, A., Cole, E., Ross, J., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12394312/

Efficacy of tranexamic acid in reducing perioperative blood ... Tranexamic acid (TXA) has been shown to effectively decrease perioperative bleeding in patients with trauma, some studies have also shown that ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1365182X25006100

Safety and efficacy of tranexamic acid in hepatic surgery Our findings suggest that TXA does not improve bleeding or mortality outcomes in liver surgeries and may increase thromboembolic risk. ... blood cell requirements ...

3. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2822555

Tranexamic Acid in Patients Undergoing Liver Resection In these large trials, tranexamic acid significantly reduced bleeding, blood transfusion, or disability due to bleeding. The HeLiX trial results ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07157631

Efficacy and Safety of Tranexamic Acid in Adult Liver ... We propose a multi-center randomized trial to test the primary hypothesis that tranexamic acid is superior to placebo on blood loss in adult ...

5. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-025-02935-0

Use of tranexamic acid in hepatectomy under controlled low ... The use of TXA in hepatectomy under CLCVP reduced the intraoperative blood transfusion rate and improved the postoperative bleeding outcome.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40484778/

Safety and efficacy of tranexamic acid in hepatic surgery Our findings suggest that TXA does not improve bleeding or mortality outcomes in liver surgeries and may increase thromboembolic risk.

7. rethinkingclinicaltrials.org rethinkingclinicaltrials.org/news/grand-rounds-november-22-2024-tranexamic-acid-versus-placebo-to-reduce-perioperative-blood-transfusion-in-patients-undergoing-liver-resection-helix-trial-paul-j-karanicolas-md-phd-frcsc/

Grand Rounds November 22, 2024: Tranexamic Acid ... Based on this trial, the study team concluded that 1) TXA does not reduce blood transfusion or bleeding in patients undergoing liver resection; ...