Comparing preoperative and postoperative blood clot prevention in pancreatic surgery
Pre- Vs. Postoperative Thromboprophylaxis in Pancreatic Surgery - a Prospective, Multicenter, Randomized Controlled Trial (PREPOSTEROUS Pancreas Trial)
This study is testing whether giving blood clot prevention medication before or after pancreatic surgery works better to keep patients safe from clots.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Helsinki University Central Hospital Academic / other |
| Locations | 5 sites (Toronto and 4 other locations) |
| Trial ID | NCT05245877 on ClinicalTrials.gov |
What this trial studies
This study investigates the timing of thromboprophylaxis in patients undergoing pancreatic surgery, specifically comparing preoperative versus postoperative administration of anticoagulants like enoxaparin, tinzaparin, or dalteparin. The research aims to address the lack of consensus and low-quality evidence surrounding thrombosis prevention in this high-risk surgical population. By conducting a prospective randomized trial, the study seeks to provide clearer guidelines for managing the balance between thrombosis and bleeding risks in pancreatic surgery patients.
Who should consider this trial
Good fit: Ideal candidates include adults undergoing pancreaticoduodenectomy, total pancreatectomy, or distal pancreatectomy for suspected cancer.
Not a fit: Patients on anticoagulant medications, those requiring emergency surgery, or individuals under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved protocols for preventing blood clots in patients undergoing pancreatic surgery, potentially reducing complications and enhancing recovery.
How similar studies have performed: While there is limited evidence from retrospective studies, this approach is novel as it aims to provide prospective data in a field lacking high-quality trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: All patients undergoing either 1. pancreaticoduodenectomy or total pancreatectomy (for any indication) or 2. distal pancreatectomy for suspicion of cancer Exclusion Criteria: 1. Patient on anticoagulative medication (heparin, low-molecular weight heparin, warfarin, direct oral anticoagulants) during the month (30 days) preceding surgery 2. Emergency operation (e.g. for trauma, infection or pancreatitis) 3. Age \< 18 years 4. Allergy or other contraindication to planned low-molecular weight heparin 5. Inability to give written informed consent 6. Pancreatic resection not performed (removed from analyses after randomization)
Where this trial is running
Toronto and 4 other locations
- Sunnybrook Health Sciences Centre — Toronto, Canada (Recruiting)
- Helsinki University Hospital — Helsinki, Finland (Recruiting)
- Oulu University Hospital — Oulu, Finland (Recruiting)
- Tampere University Hospital — Tampere, Finland (Recruiting)
- Oslo University Hospital — Oslo, 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.