Extended Thromboprophylaxis for Postoperative Clot Prevention in Liver Cancer Surgery (PRIORITY Trial)

Palo Alto (17 mi)

Overseen byAnton Skaro, MD PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Western University, Canada

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of 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 is for adults over 18 who need major liver surgery for cancer and require blood clot prevention after. They must be able to do or receive daily injections. It's not for those under 18, on current blood thinners, with a history of clots, bleeding disorders, known clotting conditions, or unable to understand English.

Inclusion Criteria

I need a major surgery to remove part of my liver for cancer.

Exclusion Criteria

I am under 18 years old.

I am currently on blood thinners.

I have had blood clots in the past.

I have a blood clotting disorder.

Treatment Details

The study tests if extended use of Redesca (90 days) is better than the standard Fragmin treatment (30 days) at preventing blood clots after liver surgery. Participants will self-inject daily and have their blood tested regularly using TEG® to monitor clotting.

2Treatment groups

Experimental Treatment

Active Control

Group I: RedescaExperimental Treatment1 Intervention

Patients in the extended thromboprophylaxis group will receive Redesca (enoxaparin sodium for injection) (40mg) once a day, starting on the day of surgery, for 90 days postoperatively.

Group II: FragminActive Control1 Intervention

Patients in the standard of care group will receive Fragmin (daletparin) (5,000 I.U) once a day, starting on the day or surgery, for 30 days postoperatively.