Pre- Vs. Postoperative Thromboprophylaxis in Pancreatic Surgery
PREPOSTEROUS2
1 other identifier
interventional
800
3 countries
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2022
Longer than P75 for phase_4
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 29, 2021
CompletedFirst Posted
Study publicly available on registry
February 18, 2022
CompletedStudy Start
First participant enrolled
August 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
February 14, 2025
February 1, 2025
4 years
December 29, 2021
February 12, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Venous thromboembolism, number of patients
Number of patients that have venous thromboembolism, which include any of the following: 1) symptomatic deep venous thromboembolism (including all deep veins e.g. all extremities, portal-, and superior mesenteric vein) diagnosed using ultrasound or computed tomography or magnetic resonance imaging, or in re-laparotomy/surgery, 2) pulmonary embolism diagnosed using computed tomography, magnetic resonance imaging, or lung perfusion imaging, or 3) death due to venous thromboembolism.
within 30 days from pancreatic resection
Secondary Outcomes (5)
Postpancreatectomy hemorrhage (PPH)
within 30 days from pancreatic resection
Comprehensive Complication Index - score
within 30 days from pancreatic resection
Length of postoperative hospital stay,
within 30 days from pancreatic resection
Transfused red blood cells
during and within 30 days from pancreas resection
Post-operative hemoglobin below 70 g/l
during and within 30 days from pancreas resection
Study Arms (2)
Preoperative thromboprophylaxis
EXPERIMENTALPreoperatively initiated tromboprophylaxis
Postoperative thromboprophylaxis
NO INTERVENTIONPostoperatively initiated thromboprophylaxis
Interventions
Patients randomized to the preoperative thromboprophylaxis will have their thromboprophylaxis initiated approximately 2-14 hours prior to the planned pancreatic surgery skin incision (depending on the center's current practice and logistics). Thromboprophylaxis can be initiated using enoxaparin (20 - 40 mg), tinzaparin (2500 - 4500 IU), or dalteparin (2500 - 5000 IU), with the dose based on patient's renal function according to the local standard of care. A center may reduce the dose 25-50% if the dose is given very close to the skin incision (i.e. at the morning of the operation instead of the evening before the operation).
Eligibility Criteria
You may qualify if:
- All patients undergoing either
- pancreaticoduodenectomy or total pancreatectomy (for any indication) or
- distal pancreatectomy for suspicion of cancer
You may not qualify if:
- Patient on anticoagulative medication (heparin, low-molecular weight heparin, warfarin, direct oral anticoagulants) during the month (30 days) preceding surgery
- Emergency operation (e.g. for trauma, infection or pancreatitis)
- Age \< 18 years
- Allergy or other contraindication to planned low-molecular weight heparin
- Inability to give written informed consent
- Pancreatic resection not performed (removed from analyses after randomization)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Sunnybrook Health Sciences Centre
Toronto, Canada
Helsinki University Hospital
Helsinki, Finland
Oulu University Hospital
Oulu, Finland
Tampere University Hospital
Tampere, Finland
Oslo University Hospital
Oslo, Norway
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Primary investigator
Study Record Dates
First Submitted
December 29, 2021
First Posted
February 18, 2022
Study Start
August 17, 2022
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
February 14, 2025
Record last verified: 2025-02