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NCT Number: NCT05245877

Pre- Vs. Postoperative Thromboprophylaxis in Pancreatic Surgery

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.

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Key information

Conditions

Pancreas Cancer Bleeding Cardiovascular Diseases Digestive System Diseases Digestive System Neoplasms Embolism and Thrombosis Endocrine Gland Neoplasms Endocrine System Diseases Hemorrhage Neoplasms Neoplasms by Site Pancreas Neoplasm Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Surgery Thrombosis Vascular Diseases

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sunnybrook Health Sciences Centre, Toronto, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

enoxaparin/tinzaparin/dalteparin

Drug

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).

Primary outcomes

  1. Venous thromboembolism, number of patients

    Time frame: within 30 days from pancreatic resection

    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.

Secondary outcomes

  1. Postpancreatectomy hemorrhage (PPH)

    Time frame: within 30 days from pancreatic resection

    Postpancreatectomy hemorrhage (PPH), any grade in ISGPS classification for postpancreatectomy hemorrhage, number of patients

  2. Comprehensive Complication Index - score

    Time frame: within 30 days from pancreatic resection

    Comprehensive Complication Index - score

  3. Length of postoperative hospital stay,

    Time frame: within 30 days from pancreatic resection

    Length of postoperative hospital stay, days, within 30 days from pancreas resection including hospital stay due to readmission(s)

  4. Transfused red blood cells

    Time frame: during and within 30 days from pancreas resection

    Total amount of transfused red blood cells, units, during and within 30 days from pancreas resection

  5. Post-operative hemoglobin below 70 g/l

    Time frame: during and within 30 days from pancreas resection

    Number of patients with post-operative hemoglobin below 70 g/l

Study contacts

Contact information is provided by the study sponsor or research team.

Ville Sallinen, MD,PhD

CONTACT

[email protected]

+358-9-4711

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

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

Acronym: PREPOSTEROUS2

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 18, 2022
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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