Clinical trial NCT06153394: Prolonged Hypercoagulability Following Major Liver Resection for Malignancy
Official title: Prolonged Hypercoagulability Following Major Liver Resection for Malignancy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Hepatic Disease
Surgery-Complications
Hypercoagulability
Thrombosis
Lead sponsor: Western University, Canada
Sponsor class: OTHER
Collaborators: name: Valeo Pharma Inc
First posted: 2023-12-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Number pf participants with hypercoagulability identified via TEG testing
timeFrame: Preoperatively (with pre-admission blood work) through to 90 days postoperatively
Secondary outcomes:
measure: Thrombotic Events
timeFrame: Up to 6 months postoperatively
measure: Disease Free Survival
timeFrame: Up to 3 years postoperatively
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: Western Univeristy/LHSC
name: Anton Skaro, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: