Pre- vs Postoperative Thromboprophylaxis for Liver Resection

Surgery Clinical Trial

— PREPOSTEROUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04731558
• Other study ID #: HYKS-PREPOSTEROUS
• Status: Recruiting
• Phase: Phase 4
• Start date: February 10, 2021
• Est. completion date: March 2025

Study information

• Verified date: September 2022
• Source: Helsinki University Central Hospital
• Contact: Ville Sallinen, MD, PhD
• Phone: +358-9-4711
• Email: ville.sallinen[@]helsinki.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1012
• Est. completion date: March 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bleeding
• Embolism
• Embolism, Pulmonary
• Liver Cancer
• Pulmonary Embolism
• Surgery
• Thrombosis
• Thrombosis, Deep Vein
• Venous Thrombosis

Intervention

Drug:
• enoxaparin or tinzaparin or dalteparin
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
No preoperative thromboprophylaxis.

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki
Finland	Kuopio University Hospital	Kuopio
Finland	Oulu University Hospital	Oulu
Finland	Tampere University Hospital	Tampere
Finland	Turku University Hospital	Turku
Norway	Oslo University Hospital	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Academy of Finland, The Finnish Medical Association

Countries where clinical trial is conducted

Finland,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venous thromboembolisms	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	within 30 days from liver resection
Secondary	Posthepatectomy haemorrhage	Number of patients with posthepatectomy haemorrhage, any grade in ISGLS classification	within 30 days from liver resection
Secondary	Postoperative complications	Comprehensive Complication Index - score	within 30 days from liver resection
Secondary	Length of postoperative hospital stay	Length of postoperative hospital stay, days	within 30 days from liver resection
Secondary	Blood transfusion	Total amount of transfused red blood cells, units	during and within 30 days from liver resection