Prolonged Hypercoagulability Following Major Liver Resection for Malignancy (PRIORITY)

Western University, Canada

Status and phase: Not yet enrolling; Phase 3

Conditions: Surgery-Complications; Thrombosis; Hypercoagulability; Hepatic Disease

Treatments: Drug: Redesca (enoxaparin sodium for injection); Drug: Fragmin (dalteparin)

Study type: Interventional

Funder types: Other

Identifiers

NCT06153394

123658

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

Redesca

Experimental group

Description:

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.

Treatment:

Drug: Redesca (enoxaparin sodium for injection)

Fragmin

Active Comparator group

Description:

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.

Treatment:

Drug: Fragmin (dalteparin)