Pre- Vs Postoperative Thromboprophylaxis for Liver Resection

NCT ID: NCT04731558

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 1012 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-10
• Study Completion Date: 2027-03-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Preoperative thromboprophylaxis

Preoperatively initiated tromboprophylaxis

Group Type: EXPERIMENTAL

enoxaparin or tinzaparin or dalteparin

Intervention Type: 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

Postoperative thromboprophylaxis

Postoperatively initiated thromboprophylaxis

Group Type: OTHER

No intervention

Intervention Type: DRUG

No preoperative thromboprophylaxis.

Interventions

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

Intervention Type: DRUG

No intervention

No preoperative thromboprophylaxis.

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Academy of Finland

OTHER

Sponsor Role: collaborator

The Finnish Medical Association

OTHER

Sponsor Role: collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ville Sallinen

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Helsinki University Hospital

Helsinki, , Finland

Site Status: RECRUITING

Kuopio University Hospital

Kuopio, , Finland

Site Status: RECRUITING

Oulu University Hospital

Oulu, , Finland

Site Status: NOT_YET_RECRUITING

Tampere University Hospital

Tampere, , Finland

Site Status: RECRUITING

Turku University Hospital

Turku, , Finland

Site Status: NOT_YET_RECRUITING

Oslo University Hospital

Oslo, , Norway

Site Status: RECRUITING

University Hospital of North Norway

Tromsø, , Norway

Site Status: RECRUITING

Countries

Finland; Norway

Central Contacts

Ville Sallinen, MD, PhD

Role: CONTACT

ville.sallinen@helsinki.fi

+358-9-4711

Facility Contacts

Aki Uutela, MD

Role: primary

aki.uutela@hus.fi

+358-9-4711

Pekka Lammi, MD

Role: primary

pekka.lammi@kys.fi

Heikki Karjula, MD, PhD

Role: primary

heikki.karjula@ppshp.fi

Yrjö Vaalavuo, MD

Role: primary

yrjo.vaalavuo@pshp.fi

Maija Lavonius, MD

Role: primary

maija.lavonius@tyks.fi

Sheraz Yaqib, MD

Role: primary

shya@ous-hf.no

Kim E Mortensen, MD, PhD

Role: primary

Kim.Erlend.Mortensen@unn.no

+47 77 62 60 00

Other Identifiers

HYKS-PREPOSTEROUS

Identifier Type: -

Identifier Source: org_study_id