Prolonged Hypercoagulability Following Major Liver Resection for Malignancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Redesca (enoxaparin sodium for injection), Fragmin (dalteparin).
- Who it may be relevant to
- Registry conditions: Hepatic Disease, Surgery-Complications, Hypercoagulability, Thrombosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- Number pf participants with hypercoagulability identified via TEG testing [Time frame: Preoperatively (with pre-admission blood work) through to 90 days postoperatively]
Secondary outcome measures (2)
- Thrombotic Events [Time frame: Up to 6 months postoperatively]
- Disease Free Survival [Time frame: Up to 3 years postoperatively]
Eligibility criteria
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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Canada · 1 center
- London Health Sciences Centre — London
Identifiers
NCT: NCT06153394 · 123658