TXA for Bleeding in Liver Surgery

(HeLiX Trial)

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

1386 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Tranexamic acid (TXA) for bleeding in liver surgery?

Tranexamic acid (TXA) has been shown to reduce bleeding and improve survival in trauma patients and is used in various surgeries to minimize bleeding. Although specific evidence for liver surgery is limited, its effectiveness in other surgical and trauma settings suggests it may help reduce bleeding during liver surgery as well. ^{1 2 3 4 5}

Is tranexamic acid (TXA) generally safe for use in humans?

Tranexamic acid (TXA) is generally considered safe for reducing bleeding in various surgeries and trauma cases, but there are concerns about potential thrombotic complications (blood clots). Safety data is more limited for certain patient groups due to their exclusion from some clinical trials. ^{1 6 7 8 9}

How is the drug TXA different from other treatments for bleeding in liver surgery?

Tranexamic acid (TXA) is unique because it is an antifibrinolytic drug, meaning it helps prevent the breakdown of blood clots, which can reduce bleeding during surgery. While it is commonly used for trauma patients, its use in liver surgery is still being studied, making it a novel option compared to standard treatments that often rely on blood transfusions. ^{1 2 3 5 10}

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.

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

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

Treatment Details

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.

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of tranexamic acid in minimizing perioperative bleeding in extrahepatic abdominal surgery: meta-analysis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Topical Tranexamic Acid for Hemostasis of an Oral Bleed in a Patient on a Direct Oral Anticoagulant. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The impact of prehospital TXA on mortality among bleeding trauma patients: A systematic review and meta-analysis. [2023]

4. England pubmed.ncbi.nlm.nih.gov

The many roles of tranexamic acid: An overview of the clinical indications for TXA in medical and surgical patients. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Tranexamic Acid to Minimise Perioperative Bleeding in Hepatic Surgery: A Systematic Review and Meta-Analysis. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Tranexamic acid for the prevention and treatment of bleeding in surgery, trauma and bleeding disorders: a narrative review. [2021]

7. Italy pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tranexamic acid in orthopaedic trauma surgery: a meta-analysis. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Exclusion criteria and adverse events in perioperative trials of tranexamic acid: a systematic review and meta-analysis. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Tranexamic acid and perioperative bleeding in children: what do we still need to know? [2019]

10. England pubmed.ncbi.nlm.nih.gov

The impact of tranexamic acid on administration of red blood cell transfusions for resection of colorectal liver metastases. [2022]