Comparing preoperative and postoperative blood clot prevention for liver surgery
Pre- Vs Postoperative Thromboprophylaxis for Liver Resection - a Prospective, Multicenter, Randomized Controlled Trial
PHASE4 · Helsinki University Central Hospital · NCT04731558
This study is testing whether giving blood clot prevention medicine before or after liver surgery works better to keep patients safe from clots.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1012 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Helsinki University Central Hospital (other) |
| Locations | 7 sites (Helsinki and 6 other locations) |
| Trial ID | NCT04731558 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the timing of thromboprophylaxis in patients undergoing liver resection, comparing preoperative versus postoperative administration of anticoagulants like enoxaparin, tinzaparin, or dalteparin. The study aims to address the lack of consensus and low-quality evidence surrounding thrombosis prevention in liver surgery, which is critical due to the associated risks of bleeding. By enrolling patients who meet specific criteria, the trial seeks to provide clearer guidelines on the optimal timing for thromboprophylaxis in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are patients scheduled for liver resection who are not on anticoagulant medications.
Not a fit: Patients who are on anticoagulant medications, require emergency surgery, or are under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved guidelines for preventing blood clots in liver surgery patients, potentially reducing complications and improving recovery.
How similar studies have performed: There is currently no known prospective randomized trial addressing this specific timing of thromboprophylaxis in liver surgery, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients undergoing liver resection Exclusion Criteria: * Patient on anticoagulative medication (heparin, low-molecular weight heparin, warfarin, direct oral anticoagulants) during last month pre-surgery * Emergency operation (e.g. for trauma or infection) * Age \< 18 years * Allergy or other contraindication to planned low-molecular weight heparin * Inability to give written informed consent * Liver resection not performed (removed from analyses after randomization)
Where this trial is running
Helsinki and 6 other locations
- Helsinki University Hospital — Helsinki, Finland (RECRUITING)
- Kuopio University Hospital — Kuopio, Finland (RECRUITING)
- Oulu University Hospital — Oulu, Finland (NOT_YET_RECRUITING)
- Tampere University Hospital — Tampere, Finland (RECRUITING)
- Turku University Hospital — Turku, Finland (NOT_YET_RECRUITING)
- Oslo University Hospital — Oslo, Norway (RECRUITING)
- University Hospital of North Norway — Tromsø, Norway (RECRUITING)
Study contacts
- Study coordinator: Ville Sallinen, MD, PhD
- Email: ville.sallinen@helsinki.fi
- Phone: +358-9-4711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Liver Cancer, Surgery, Thrombosis, Deep Vein, Embolism, Pulmonary, Bleeding