Pre- Vs. Postoperative Thromboprophylaxis in Pancreatic Surgery - a Prospective, Multicenter, Randomized Controlled Trial (PREPOSTEROUS Pancreas Trial)

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 120
Healthy Volunteers: f
View:

⁃ All patients undergoing either

• pancreaticoduodenectomy or total pancreatectomy (for any indication) or

• distal pancreatectomy for suspicion of cancer

Locations
Other Locations
Canada
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
Finland
Helsinki University Hospital
RECRUITING
Helsinki
Oulu University Hospital
RECRUITING
Oulu
Tampere University Hospital
RECRUITING
Tampere
Norway
Oslo University Hospital
RECRUITING
Oslo
Contact Information
Primary
Ville Sallinen, MD,PhD
ville.sallinen@helsinki.fi
+358-9-4711
Time Frame
Start Date: 2022-08-17
Estimated Completion Date: 2026-09
Participants
Target number of participants: 800
Treatments
Experimental: Preoperative thromboprophylaxis
Preoperatively initiated tromboprophylaxis
No_intervention: Postoperative thromboprophylaxis
Postoperatively initiated thromboprophylaxis
Sponsors
Leads: Helsinki University Central Hospital

This content was sourced from clinicaltrials.gov