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Recruiting NCT05245877

Pre- Vs. Postoperative Thromboprophylaxis in Pancreatic Surgery

Phase IV Interventional Pancreas Cancer Pancreas Neoplasm Surgery Thrombosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: enoxaparin/tinzaparin/dalteparin.
Who it may be relevant to
Registry conditions: Pancreas Cancer, Pancreas Neoplasm, Surgery, Thrombosis. Basic parameters: 18 years — 120 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada, Finland, Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug enoxaparin/tinzaparin/dalteparin
    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 t

Primary outcome measures

  • Venous thromboembolism, number of patients [Time frame: within 30 days from pancreatic resection]
Secondary outcome measures (5)
  • Postpancreatectomy hemorrhage (PPH) [Time frame: within 30 days from pancreatic resection]
  • Comprehensive Complication Index - score [Time frame: within 30 days from pancreatic resection]
  • Length of postoperative hospital stay, [Time frame: within 30 days from pancreatic resection]
  • Transfused red blood cells [Time frame: during and within 30 days from pancreas resection]
  • Post-operative hemoglobin below 70 g/l [Time frame: during and within 30 days from pancreas resection]

Eligibility criteria

Inclusion criteria

All patients undergoing either

  • pancreaticoduodenectomy or total pancreatectomy (for any indication) or
  • distal pancreatectomy for suspicion of cancer

Exclusion criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Finland · 3 centers
  • Helsinki University Hospital — Helsinki
  • Oulu University Hospital — Oulu
  • Tampere University Hospital — Tampere
Canada · 1 center
  • Sunnybrook Health Sciences Centre — Toronto
Norway · 1 center
  • Oslo University Hospital — Oslo

Identifiers

NCT: NCT05245877 · HYKS-PREPOSTEROUS2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗