PREPOSTEROUS: Pre- vs Postoperative Thromboprophylaxis for Liver Resection

Sponsor
Helsinki University Central Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04731558
Collaborator
Academy of Finland (Other), The Finnish Medical Association (Other)
1,012
6
2
48.6
168.7
3.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: enoxaparin or tinzaparin or dalteparin
  • Drug: No intervention
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1012 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Pre- vs Postoperative Thromboprophylaxis for Liver Resection - a Prospective, Multicenter, Randomized Controlled Trial
Actual Study Start Date :
Feb 10, 2021
Anticipated Primary Completion Date :
Feb 1, 2025
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Preoperative thromboprophylaxis

Preoperatively initiated tromboprophylaxis

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

Other: Postoperative thromboprophylaxis

Postoperatively initiated thromboprophylaxis

Drug: No intervention
No preoperative thromboprophylaxis.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Posthepatectomy haemorrhage [within 30 days from liver resection]

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

  2. Postoperative complications [within 30 days from liver resection]

    Comprehensive Complication Index - score

  3. Length of postoperative hospital stay [within 30 days from liver resection]

    Length of postoperative hospital stay, days

  4. Blood transfusion [during and within 30 days from liver resection]

    Total amount of transfused red blood cells, units

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Helsinki University Hospital Helsinki Finland
2 Kuopio University Hospital Kuopio Finland
3 Oulu University Hospital Oulu Finland
4 Tampere University Hospital Tampere Finland
5 Turku University Hospital Turku Finland
6 Oslo University Hospital Oslo Norway

Sponsors and Collaborators

  • Helsinki University Central Hospital
  • Academy of Finland
  • The Finnish Medical Association

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ville Sallinen, Principal investigator, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT04731558
Other Study ID Numbers:
  • HYKS-PREPOSTEROUS
First Posted:
Feb 1, 2021
Last Update Posted:
Jun 3, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 3, 2021