Prolonged Hypercoagulability Following Major Liver Resection for Malignancy

Thrombosis Clinical Trial

— PRIORITY  

Official title:

Prolonged Hypercoagulability Following Major Liver Resection for Malignancy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06153394
• Other study ID #: 123658
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 1, 2024
• Est. completion date: February 1, 2028

Study information

• Verified date: April 2024
• Source: Western University, Canada
• Contact: Crystal Engelage, PhD
• Phone: 519-685-8500
• Email: Crystal.Engelage[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: February 1, 2028
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatic Disease
• Hypercoagulability
• Liver Diseases
• Thrombophilia
• Thrombosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Western University, Canada	Valeo Pharma Inc

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number pf participants with hypercoagulability identified via TEG testing	All participants will have postoperative TEG testing performed for the detection of hypercoagulability.	Preoperatively (with pre-admission blood work) through to 90 days postoperatively
Secondary	Thrombotic Events	Determining the occurrence of postoperative venous thrombotic events between treatment groups	Up to 6 months postoperatively
Secondary	Disease Free Survival	Comparing disease free survival (DFS) rates between treatment groups	Up to 3 years postoperatively