PRIORITY: Prolonged Hypercoagulability Following Major Liver Resection for Malignancy

Sponsor

Western University, Canada (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06153394

Collaborator

Valeo Pharma Inc (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Disease Surgery-Complications Hypercoagulability Thrombosis	Drug: Redesca (enoxaparin sodium for injection) Drug: Fragmin (dalteparin)	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Prolonged Hypercoagulability Following Major Liver Resection for Malignancy

Anticipated Study Start Date :

Feb 1, 2024

Anticipated Primary Completion Date :

Feb 1, 2025

Anticipated Study Completion Date :

Feb 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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.
Active Comparator: 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.	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.

Arm

Intervention/Treatment

Experimental: 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.

Drug: 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.

Active Comparator: 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.

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.

Outcome Measures

Primary Outcome Measures

Identification of hypercoagulability via TEG testing [Preoperatively (with pre-admission blood work) through to 90 days postoperatively]
All participants will have postoperative TEG testing performed for the detection of hypercoagulability.

Secondary Outcome Measures

Thrombotic Events [Up to 6 months postoperatively]
Determining the occurrence of postoperative venous thrombotic events between treatment groups
Disease Free Survival [Up to 3 years postoperatively]
Comparing disease free survival (DFS) rates between treatment groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.