Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06153394

Prolonged Hypercoagulability Following Major Liver Resection for Malignancy

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Redesca (enoxaparin sodium for injection)

Drug

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)

Drug

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 outcomes

  1. Number pf participants with hypercoagulability identified via TEG testing

    Time frame: 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 outcomes

  1. Thrombotic Events

    Time frame: Up to 6 months postoperatively

    Determining the occurrence of postoperative venous thrombotic events between treatment groups

  2. Disease Free Survival

    Time frame: Up to 3 years postoperatively

    Comparing disease free survival (DFS) rates between treatment groups

Study contacts

Contact information is provided by the study sponsor or research team.

Crystal Engelage, PhD

CONTACT

[email protected]

519-685-8500 ext. 37517

Sponsors and collaborators

Lead sponsor

Western University, Canada

Other

Collaborators

  • Valeo Pharma Inc

Registry information

Acronym: PRIORITY

Important dates

Study start
2024
Primary completion
2025
Study completion
2028
First posted
Dec 1, 2023
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.