Prolonged Hypercoagulability Following Major Liver Resection for Malignancy
- Conditions
- Hepatic DiseaseSurgery-ComplicationsHypercoagulabilityThrombosis
- Interventions
- Drug: Redesca (enoxaparin sodium for injection)
- Registration Number
- NCT06153394
- Lead Sponsor
- Western University, Canada
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Redesca Redesca (enoxaparin sodium for injection) 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. Fragmin Fragmin (dalteparin) 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.
- Primary Outcome Measures
Name Time Method Number pf participants with hypercoagulability identified 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
Name Time Method 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
Trial Locations
- Locations (1)
London Health Sciences Centre
🇨🇦London, Ontario, Canada