Extended Thromboprophylaxis for Postoperative Clot Prevention in Liver Cancer Surgery

(PRIORITY Trial)

Overseen By Crystal Engelage, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Western University, Canada

Must be taking: Low molecular weight heparins

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Thrombotic events, Coagulation disorder, Thrombophilia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 30-90 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to prevent blood clots in patients after liver cancer surgery. It focuses on thromboelastography (TEG), a test that might better detect clotting issues, and compares two treatments: an extended 90-day course of Redesca (an anticoagulant) and a standard 30-day course of Fragmin (an anticoagulant). Participants will administer daily injections of these medications, similar to insulin shots, and undergo blood tests to monitor clotting. Those who have undergone major liver surgery for cancer and can manage daily injections are well-suited for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial requires that participants are not on current anticoagulant or antiplatelet therapy, so you would need to stop these medications to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that enoxaparin, the main ingredient in Redesca, is generally safe for patients undergoing cancer surgery. One study demonstrated that using enoxaparin for four weeks post-surgery significantly reduced the risk of blood clots without major safety issues. Another study found enoxaparin safe for patients having surgery on the liver and nearby cancer-affected organs.

Fragmin, another blood thinner, is commonly used to prevent blood clots after surgery. It is well-tolerated and has been widely used in similar cases.

Both Redesca and Fragmin lower the risk of dangerous blood clots. While generally safe, they can cause side effects like bruising or bleeding, common with blood thinners. Researchers will closely monitor trial participants to ensure their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatment for preventing blood clots after liver cancer surgery, which typically involves a shorter course of medication, Redesca offers an extended approach with enoxaparin sodium. Researchers are excited about Redesca because it is administered for 90 days post-surgery, compared to the usual 30 days, potentially providing more comprehensive clot prevention during recovery. This longer course might reduce the risk of postoperative complications, offering patients a smoother healing process.

What evidence suggests that this trial's treatments could be effective for preventing blood clots after liver cancer surgery?

In this trial, participants will receive either Redesca (enoxaparin) or Fragmin (dalteparin) to prevent blood clots after liver cancer surgery. Research has shown that using Redesca (enoxaparin) after such surgery can help prevent clots in the liver's main vein. Studies have found that enoxaparin reduces the risk of blood clots in veins following abdominal cancer surgeries. Prolonged use of blood thinners like Redesca may offer better protection against clots than shorter use. This suggests that continuing blood thinner treatment could help prevent clotting issues after liver cancer surgery. ^{2 6 7 8 9}

Who Is on the Research Team?

Anton Skaro, MD PhD

Principal Investigator

Western Univeristy/LHSC

Are You a Good Fit for This Trial?

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.

I need medication to prevent blood clots after surgery.

I can give myself injections or have someone who can do it for me.

Exclusion Criteria

I am under 18 years old.

I am currently on blood thinners.

I have had blood clots in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Testing

Participants undergo TEG testing and pre-admission blood work

1 week

1 visit (in-person)

Treatment

Participants receive thromboprophylaxis with either Redesca for 90 days or Fragmin for 30 days post-surgery

30-90 days

Daily self-injections

Postoperative Monitoring

Participants are monitored for clotting complications and undergo TEG testing on post-operative days 1, 3, 5, 30, and 90

90 days

5 visits (in-person)

Follow-up

Participants are monitored for thrombotic events and disease-free survival

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Fragmin
• Redesca

Trial Overview 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.

How Is the Trial Designed?

Group I: Redesca Experimental Treatment 1 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: Fragmin Active Control 1 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.

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

Valeo Pharma Inc

Collaborator

Trials

1

Recruited

50+

Published Research Related to This Trial

In a study involving 614 patients undergoing colorectal cancer surgery, extended duration thromboprophylaxis with tinzaparin did not significantly improve disease-free survival compared to standard in-hospital thromboprophylaxis, with similar outcomes observed in both groups.

The rates of venous thromboembolism and major bleeding complications were low and comparable between the extended duration and in-hospital groups, indicating that both approaches are safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of extended duration to perioperative thromboprophylaxis with low molecular weight heparin on disease-free survival after surgical resection of colorectal cancer (PERIOP-01): multicentre, open label, randomised controlled trial. Auer, RC., Ott, M., Karanicolas, P., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11368486/

Randomized, controlled, multi‐center phase II study of ... Postoperative venous thromboembolism (VTE) risk is pronounced after abdominal cancer surgery. Enoxaparin shows promise in preventing VTE in gastrointestinal ...

2. researchgate.net researchgate.net/publication/265054542_Efficacy_of_postoperative_anticoagulation_therapy_with_enoxaparin_for_portal_vein_thrombosis_after_hepatic_resection_in_patients_with_liver_cancer

Efficacy of postoperative anticoagulation therapy with ... Conclusions: Postoperative anticoagulant therapy with enoxaparin could prevent PVT in patients who underwent hepatic resection for liver cancers ...

3. withpower.com withpower.com/trial/extended-thromboprophylaxis-for-postoperative-clot-prevention-in-liver-cancer-surgery-9fac4

Extended Thromboprophylaxis for Postoperative Clot ... This suggests that using blood thinners like Fragmin and Redesca can help prevent clots after liver cancer surgery.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25156238/

Efficacy of postoperative anticoagulation therapy with ... Conclusions: Postoperative anticoagulant therapy with enoxaparin could prevent PVT in patients who underwent hepatic resection for liver cancers ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa012385

Duration of Prophylaxis against Venous Thromboembolism ... Abdominal surgery for cancer carries a high risk of venous thromboembolism, but the optimal duration of postoperative thromboprophylaxis is unknown.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11154512/

Update on the Pharmacological Actions of Enoxaparin in ... The trial showed enoxaparin is preferable, reducing the risk of venous thromboembolism by 43% compared with unfractionated heparin, with a ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/ags3.12796

Randomized, controlled, multi‐center phase II study of ... We confirmed the safety of enoxaparin administration in patients undergoing curative hepatobiliary-pancreatic surgery for malignancies in a prospective, multi- ...

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.19.01461

Venous Thromboembolism Prophylaxis and Treatment in ... In the 2016 Cochrane review by Di Nisio et al, LMWH reduced the risk of symptomatic VTE by roughly half (RR, 0.54; 95% CI, 0.38 to 0.75) ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06153394

Prolonged Hypercoagulability Following Major Liver ... 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 ...