Prolonged Hypercoagulability Following Major Liver Resection for Malignancy

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorWestern University, Canada

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: RedescaExperimental treatment 1 intervention
Group B: FragminActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number pf participants with hypercoagulability identified via TEG testing

All participants will have postoperative TEG testing performed for the detection of hypercoagulability.

Time frame
Preoperatively (with pre-admission blood work) through to 90 days postoperatively

Secondary outcomes

1

Thrombotic Events

Determining the occurrence of postoperative venous thrombotic events between treatment groups

Time frame
Up to 6 months postoperatively
2

Disease Free Survival

Comparing disease free survival (DFS) rates between treatment groups

Time frame
Up to 3 years postoperatively

Other outcomes

Sponsors and contacts

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Western University, Canada

Lead sponsor

Valeo Pharma Inc

Collaborator

This trial is not recruiting at the moment. You can still explore other options: