Pre- Vs Postoperative Thromboprophylaxis for Liver Resection

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorHelsinki University Central Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients undergoing liver resection

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

1,012 Participants
are divided into 2 treatment groups
Group A: Preoperative thromboprophylaxisExperimental treatment 1 intervention
Group B: Postoperative thromboprophylaxisOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
within 30 days from liver resection

Secondary outcomes

1

Posthepatectomy haemorrhage

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

Time frame
within 30 days from liver resection
2

Postoperative complications

Comprehensive Complication Index - score

Time frame
within 30 days from liver resection
3

Length of postoperative hospital stay

Length of postoperative hospital stay, days

Time frame
within 30 days from liver resection
4

Blood transfusion

Total amount of transfused red blood cells, units

Time frame
during and within 30 days from liver resection

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Helsinki University Central Hospital

Lead sponsor

Academy of Finland

Collaborator

The Finnish Medical Association

Collaborator