Actively Recruiting
Pre- Vs. Postoperative Thromboprophylaxis in Pancreatic Surgery - a Prospective, Multicenter, Randomized Controlled Trial (PREPOSTEROUS Pancreas Trial)
Led by Helsinki University Central Hospital · Updated on 2025-02-14
800
Participants Needed
5
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating when to start blood clot prevention (thromboprophylaxis) for patients undergoing pancreatic surgery. This study compares starting thromboprophylaxis before surgery versus after surgery. There is no clear international agreement on the best timing, and current guidelines vary, with some recommending preoperative start and others postoperative. This trial aims to provide stronger evidence through a randomized controlled design. Participants will be randomly assigned to one of two groups: one group will begin thromboprophylaxis about 2 to 14 hours before the pancreatic surgery incision using medications such as enoxaparin, tinzaparin, or dalteparin, with doses adjusted for kidney function. The other group will start thromboprophylaxis after surgery, following standard care. This study is conducted across multiple centers and uses a triple-blind approach. During the study, researchers will monitor for blood clots within 30 days after surgery as the main outcome. They will also track bleeding complications, overall surgical complications, hospital stay length, blood transfusions, and low blood hemoglobin levels during this period. Participants will be followed closely for these outcomes to assess the effects of the timing of thromboprophylaxis initiation. The study started in August 2022 and is planned to continue until September 2026.
CONDITIONS
Brief Title
Pre- Vs. Postoperative Thromboprophylaxis in Pancreatic Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing pancreaticoduodenectomy or total pancreatectomy for any reason
- Patients undergoing distal pancreatectomy due to suspicion of cancer
- Age 18 years or older
- Able to provide written informed consent
You will not qualify if you...
- Use of anticoagulant medication (heparin, low-molecular weight heparin, warfarin, direct oral anticoagulants) in the 30 days before surgery
- Emergency surgery for trauma, infection, or pancreatitis
- Age under 18 years
- Allergy or contraindication to planned low-molecular weight heparin
- Unable to give written informed consent
- Pancreatic resection not performed after randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days from pancreatic surgery
Participants receive thromboprophylaxis either before or after pancreatic surgery as part of the trial intervention. The preoperative group starts medication 2 to 14 hours prior to surgery, while the postoperative group begins after surgery.
1 surgery visit and follow-up visits during the 30 days after surgery
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
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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