Pre- Vs Postoperative Thromboprophylaxis for Liver Resection (PREPOSTEROUS)

Helsinki University Central Hospital (HUCH)

Status and phase: Enrolling; Phase 4

Conditions: Embolism, Pulmonary; Surgery; Thrombosis, Deep Vein; Liver Cancer; Bleeding

Treatments: Drug: No intervention; Drug: enoxaparin or tinzaparin or dalteparin

Study type: Interventional

Funder types: Other

Identifiers

NCT04731558

HYKS-PREPOSTEROUS

Details and patient eligibility

About

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.

Enrollment: 1,012 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,012 participants in 2 patient groups

Preoperative thromboprophylaxis

Experimental group

Description:

Preoperatively initiated tromboprophylaxis

Treatment:

Drug: enoxaparin or tinzaparin or dalteparin

Postoperative thromboprophylaxis

Other group

Description:

Postoperatively initiated thromboprophylaxis

Treatment:

Drug: No intervention