Clinical Trial

Pre- Vs. Postoperative Thromboprophylaxis in Pancreatic Surgery

Study acronym: PREPOSTEROUS2
Recruiting Phase 4
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Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2022-02-08; most recent amendment 2025-02-12.
Status change: Not Yet Recruiting → Recruiting 2022-09-21
Trial Details
NCT Number NCT05245877
Lead Sponsor Helsinki University Central Hospital
Conditions Pancreas Cancer, Pancreas Neoplasm, Surgery, Thrombosis, Bleeding
Enrollment 800 participants
Start Date 2022-08-17
Primary Completion 2026-08 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2025-02-14