Extended Thromboprophylaxis for Postoperative Clot Prevention in Liver Cancer Surgery
(PRIORITY Trial)
Trial Summary
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.
What data supports the effectiveness of the drug Fragmin, Redesca for preventing clots after liver cancer surgery?
Is the treatment for preventing blood clots after liver cancer surgery safe?
How is extended thromboprophylaxis unique for preventing clots after liver cancer surgery?
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.
Research Team
Anton Skaro, MD PhD
Principal Investigator
Western Univeristy/LHSC
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Testing
Participants undergo TEG testing and pre-admission blood work
Treatment
Participants receive thromboprophylaxis with either Redesca for 90 days or Fragmin for 30 days post-surgery
Postoperative Monitoring
Participants are monitored for clotting complications and undergo TEG testing on post-operative days 1, 3, 5, 30, and 90
Follow-up
Participants are monitored for thrombotic events and disease-free survival
Treatment Details
Interventions
- Fragmin
- Redesca
Find a Clinic Near You
Who Is Running the Clinical Trial?
Western University, Canada
Lead Sponsor
Valeo Pharma Inc
Collaborator