NCT05245877RecruitingPhase 4
Pre- Vs. Postoperative Thromboprophylaxis in Pancreatic Surgery
Pre- Vs. Postoperative Thromboprophylaxis in Pancreatic Surgery - a Prospective, Multicenter, Randomized Controlled Trial (PREPOSTEROUS Pancreas Trial)
Source: ClinicalTrials.gov · Last updated 14 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Thromboprophylaxis for pancreatic surgery can be commenced either preoperatively or postoperatively. Despite a clear trade-off between thrombosis and bleeding in pancreatic surgery patients, there is no international consensus when thrombosis prophylaxis should be commenced in patients undergoing pancreatic surgery. There are no prospective randomized trials in this field, and current guidelines are unfortunately based on very low quality evidence, that is, a few retrospective studies and expert opinion. Both American and European thromboprophylaxis guidelines for abdominal cancer surgery support the preoperative initiation of thromboprophylaxis, but these guidelines do not specifically address the increased bleeding risk associated with pancreatic surgery. On the contrary, Dutch guidelines recommend postoperative thromboprophylaxis only, because of lack of evidence for preoperative thromboprophylaxis. Enhanced Recovery After Surgery (ERAS) Society Guidelines recommend preoperative thromboprophylaxis in pancreatic surgery, but the guidelines provide no supporting evidence for this recommendation. Overall, the amount of evidence is scarce and somewhat contradictory in this clinically relevant field of thromboprophylaxis in pancreatic surgery. The aim of this study is to compare pre- and postoperatively initiated thromboprophylaxis regimens in pancreatic surgery in a randomized controlled trial.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 800 (estimated)
- First submitted
- 29 Dec 2021
- Start date
- 17 Aug 2022
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- Helsinki University Central Hospital
- Diseases
- Pancreatic cancer
- NCT number
- NCT05245877
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 800
- From 17 Aug 2022 to the primary completion date, 31 Aug 2026
- 5 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient on anticoagulative medication (heparin, low-molecular weight heparin, warfarin, direct oral anticoagulants) during the month (30 days) preceding surgery
- Pancreatic resection not performed (removed from analyses after randomization)
Other illness
- Emergency operation (e.g. for trauma, infection or pancreatitis)
- Allergy or other contraindication to planned low-molecular weight heparin
Age
- Age \< 18 years
Other
- Inability to give written informed consent
Who the study is looking for
- All patients undergoing either
- pancreaticoduodenectomy or total pancreatectomy (for any indication) or
- distal pancreatectomy for suspicion of cancer
Age in the registry: 18 years to 120 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Helsinki University Hospital Coordinator of this site? Confirm its status | Helsinki | Finland | Recruiting |
| Oulu University Hospital Coordinator of this site? Confirm its status | Oulu | Finland | Recruiting |
| Tampere University Hospital Coordinator of this site? Confirm its status | Tampere | Finland | Recruiting |
| Oslo University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.