Prolonged Hypercoagulability Following Major Liver Resection for Malignancy

NCT ID: NCT06153394

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2028-02-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Redesca

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.

Group Type: EXPERIMENTAL

Redesca (enoxaparin sodium for injection)

Intervention Type: 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.

Fragmin

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.

Group Type: ACTIVE_COMPARATOR

Fragmin (dalteparin)

Intervention Type: 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.

Interventions

Redesca (enoxaparin sodium for injection)

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.

Intervention Type: DRUG

Fragmin (dalteparin)

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Adults aged 18 years or older at the time of enrollment.

2. Requiring major liver resection (>2 liver sections) for any oncologic indication.

3. Requiring postoperative thromboprophylaxis will be included.

4. Willing and able to perform subcutaneous injections according to the study protocol, or receive injections form a caregiver delegated by the participant.

Exclusion Criteria

1. Anyone below 18 years of age.

2. Patients on current anticoagulant and/or antiplatelet therapy

3. Patients with a history of thrombotic events

4. Patients with a coagulation disorder.

5. Patients with recognized thrombophilia.

6. Patients who cannot understand/speak or read in English.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Valeo Pharma Inc

UNKNOWN

Sponsor Role: collaborator

Western University, Canada

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anton Skaro, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Western Univeristy/LHSC

Locations

London Health Sciences Centre

London, Ontario, Canada

Countries

Canada

Central Contacts

Crystal Engelage, PhD

Role: CONTACT

Crystal.Engelage@lhsc.on.ca

519-685-8500 ext. 37517

Other Identifiers

123658

Identifier Type: -

Identifier Source: org_study_id