Prolonged Hypercoagulability Following Major Liver Resection for Malignancy

NCT06153394 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 123658
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial will investigate the ability of thromboelastrogrpahy (TEG®) to detect hypercoagulability after liver surgery and will examine the effect of extended thromboprophylaxis (medical treatment to prevent the development of blood clots inside blood vessels) in patients undergoing liver surgery for cancer treatment. The liver plays a key role in regulating the process of blood clotting. As a result, blood clots are a major cause of complications and death following liver surgery. This is especially true in cancer patients who are at a higher risk of developing blood clots. Current methods for preventing clotting complications after liver surgery include conventional coagulation blood tests (CCTs) and anticoagulant drugs, such as low molecular weight heparins (LMWHs). Current LMWH treatment is prescribed for one month after surgery, but studies show that the risk of developing blood clots can last up to 3 months. Studies also show that CCTs may not be as effective in detecting clotting issues as more comprehensive testing systems, such as TEG. This study will randomize 50 participants to receive 90 days of thromboprophylaxis (using the LMWH Redesca) or the standard of care 30 days (using the LMWH Fragmin) after liver surgery. The medication will be given by injection, similar to a regular vaccine or an insulin injection. Participants will inject the medication every day, for 30 or 90 days, after surgery. Participants will also have their blood tested for clotting issues via TEG testing before surgery and on post-operative days 1,3,5,30 and 90. After surgery, participants will be monitored by their surgeon for clotting complications and 3 year disease-free survival.

Conditions

Hepatic Disease; Surgery-Complications; Hypercoagulability; Thrombosis

Outcome Measures

Primary Outcomes (1)

• Number pf participants with hypercoagulability identified via TEG testing

  All participants will have postoperative TEG testing performed for the detection of hypercoagulability.

  Preoperatively (with pre-admission blood work) through to 90 days postoperatively

Secondary Outcomes (2)

• Thrombotic Events

  Up to 6 months postoperatively

• Disease Free Survival

  Up to 3 years postoperatively

Study Arms (2)

Redesca

EXPERIMENTAL

Patients in the extended thromboprophylaxis group will receive Redesca (enoxaparin sodium for injection) (40mg) once a day, starting on the day of surgery, for 90 days postoperatively.

Drug: Redesca (enoxaparin sodium for injection)

Fragmin

ACTIVE COMPARATOR

Patients in the standard of care group will receive Fragmin (daletparin) (5,000 I.U) once a day, starting on the day or surgery, for 30 days postoperatively.

Drug: Fragmin (dalteparin)

Interventions

Redesca (enoxaparin sodium for injection) DRUG

Redesca is low molecular weight heparin and a biosimilar biologic drug (biosimilar) to Lovenox. Indications have been granted on the basis of similarity between Redesca and the reference biologic drug Lovenox. As such, Redesca (enoxaparin sodium) is indicated for thromboprophylaxis in patients undergoing high risk abdominal and colorectal surgeries. Doses are provided as self-administered subcutaneous injections using a pre-filled syringe with a protective shield.

Redesca

Fragmin (dalteparin) DRUG

Fragmin is a low molecular weight heparin indicated for thromboprophylaxis in patients undergoing high risk abdominal and colorectal surgeries. Doses are provided as self-administered subcutaneous injections using a pre-filled syringe with a protective shield. Our institution uses this drug for standard of care thromboprophylaxis (30 days) in this patient population.

Fragmin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older at the time of enrollment.
• Requiring major liver resection (\>2 liver sections) for any oncologic indication.
• Requiring postoperative thromboprophylaxis will be included.
• Willing and able to perform subcutaneous injections according to the study protocol, or receive injections form a caregiver delegated by the participant.

You may not qualify if:

• Anyone below 18 years of age.
• Patients on current anticoagulant and/or antiplatelet therapy
• Patients with a history of thrombotic events
• Patients with a coagulation disorder.
• Patients with recognized thrombophilia.
• Patients who cannot understand/speak or read in English.

Sponsors & Collaborators

• Western University, Canada: lead
• Valeo Pharma Inc: collaborator

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Digestive System Diseases; Thrombophilia; Thrombosis

Interventions

enoxaparin sodium; Injections; Dalteparin

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Anton Skaro, MD PhD

  Western Univeristy/LHSC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Crystal Engelage, PhD

CONTACT

519-685-8500; Crystal.Engelage@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a phase III pilot trial where 50 participants will be randomized 1:1 to receive extended duration thromboprophylaxis via Redesca or standard of care thromboprophylaxis via Fragmin. Participants will be followed for 3 years after surgery.

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 1, 2023
• Study Start: June 1, 2024
• Primary Completion: February 1, 2025
• Study Completion (Estimated): February 1, 2028
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)