Actively Recruiting

Phase 4
Age: 18Years - 120Years
All Genders
NCT05245877

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

Age: 18Years - 120Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • All patients undergoing pancreaticoduodenectomy or total pancreatectomy for any reason
  • All patients undergoing distal pancreatectomy for suspected cancer
Not Eligible

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

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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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