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NCT Number: NCT04731558

Pre- Vs Postoperative Thromboprophylaxis for Liver Resection

Thromboprophylaxis for liver surgery can be commenced either preoperatively or postoperatively. Despite a clear trade-off between thrombosis and bleeding in liver surgery patients, there is no international consensus when thrombosis prophylaxis should be commenced in patients undergoing liver surgery. As far as we know, 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 liver surgery. On the contrary, Dutch guidelines recommend postoperative thromboprophylaxis only, because of lack of evidence for preoperative thromboprophylaxis. Traditionally, many liver surgery units have been reluctant in using preoperative thromboprophylaxis due to the potentially increased risk of bleeding complications. Enhanced Recovery After Surgery (ERAS) Society Guidelines recommend preoperative thromboprophylaxis in liver 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 liver surgery. The aim of this study is to compare pre- and postoperatively initiated thromboprophylaxis regimens in liver surgery in a randomized controlled trial.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients undergoing liver resection

Exclusion criteria

  • Patient on anticoagulative medication (heparin, low-molecular weight heparin, warfarin, direct oral anticoagulants) during last month pre-surgery
  • Emergency operation (e.g. for trauma or infection)
  • Age < 18 years
  • Allergy or other contraindication to planned low-molecular weight heparin
  • Inability to give written informed consent
  • Liver resection not performed (removed from analyses after randomization)

Treatment and study plan

enoxaparin or tinzaparin or dalteparin

Drug

Thromboprophylaxis initiated approximately 14 hours prior to the planned liver resection skin incision. 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

No intervention

Drug

No preoperative thromboprophylaxis.

Primary outcomes

  1. Venous thromboembolisms

    Time frame: within 30 days from liver resection

    Number of patients with venous thromboembolism defined as either 1) symptomatic deep venous thromboembolism (includes all deep veins e.g. all extremities, portal vein, and superior mesenteric) diagnosed using ultrasound or computed tomography or magnetic resonance imaging, or in re-laparatomy/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. Posthepatectomy haemorrhage

    Time frame: within 30 days from liver resection

    Number of patients with posthepatectomy haemorrhage, any grade in ISGLS classification

  2. Postoperative complications

    Time frame: within 30 days from liver resection

    Comprehensive Complication Index - score

  3. Length of postoperative hospital stay

    Time frame: within 30 days from liver resection

    Length of postoperative hospital stay, days

  4. Blood transfusion

    Time frame: during and within 30 days from liver resection

    Total amount of transfused red blood cells, units

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

Collaborators

  • Academy of Finland
  • The Finnish Medical Association

Registry information

Official study title

Pre- Vs Postoperative Thromboprophylaxis for Liver Resection - a Prospective, Multicenter, Randomized Controlled Trial

Acronym: PREPOSTEROUS

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Feb 1, 2021
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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