Actively Recruiting
Pre- Vs. Postoperative Thromboprophylaxis in Pancreatic Surgery
Led by Helsinki University Central Hospital · Updated on 2025-02-14
800
Participants Needed
5
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pre- Vs. Postoperative Thromboprophylaxis in Pancreatic Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All patients undergoing pancreaticoduodenectomy or total pancreatectomy for any reason
- All patients undergoing distal pancreatectomy for suspected cancer
You will not qualify if you...
- Use of anticoagulant medication (heparin, low-molecular weight heparin, warfarin, direct oral anticoagulants) within 30 days before surgery
- Emergency pancreatic surgery for trauma, infection, or pancreatitis
- Age under 18 years
- Allergy or contraindication to planned low-molecular weight heparin
- Unable to provide written informed consent
- Pancreatic resection not performed after randomization
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Sunnybrook Health Sciences Centre
Toronto, Canada
Actively Recruiting
2
Helsinki University Hospital
Helsinki, Finland
Actively Recruiting
3
Oulu University Hospital
Oulu, Finland
Actively Recruiting
4
Tampere University Hospital
Tampere, Finland
Actively Recruiting
5
Oslo University Hospital
Oslo, Norway
Actively Recruiting
Research Team
V
Ville Sallinen, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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