Pre- Vs Postoperative Thromboprophylaxis for Liver Resection

Phase 4

Recruiting

• Conditions: Liver Cancer; Surgery; Thrombosis, Deep Vein; Embolism, Pulmonary; Bleeding
• Interventions: Drug: No intervention; Drug: enoxaparin or tinzaparin or dalteparin

• Registration Number: NCT04731558
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-26
• Study First Submitted QC: 2021-01-26
• Study First Posted: 2021-02-01
• Study Start: 2021-02-10
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14
• Primary Completion: 2027-02
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1012

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Postoperative thromboprophylaxis	No intervention	Postoperatively initiated thromboprophylaxis
Preoperative thromboprophylaxis	enoxaparin or tinzaparin or dalteparin	Preoperatively initiated tromboprophylaxis

Primary Outcome Measures

Name	Time	Method
Venous thromboembolisms	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 Outcome Measures

Name	Time	Method
Posthepatectomy haemorrhage	within 30 days from liver resection	Number of patients with posthepatectomy haemorrhage, any grade in ISGLS classification
Postoperative complications	within 30 days from liver resection	Comprehensive Complication Index - score
Length of postoperative hospital stay	within 30 days from liver resection	Length of postoperative hospital stay, days
Blood transfusion	during and within 30 days from liver resection	Total amount of transfused red blood cells, units

Trial Locations

Locations (7)

University Hospital of North Norway; 🇳🇴 Tromsø, Norway

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Kuopio University Hospital; 🇫🇮 Kuopio, Finland

Oulu University Hospital; 🇫🇮 Oulu, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland

Turku University Hospital; 🇫🇮 Turku, Finland

Oslo University Hospital; 🇳🇴 Oslo, Norway