RecruitingPhase 4NCT04731558

Pre- Vs Postoperative Thromboprophylaxis for Liver Resection

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


Sponsor

Helsinki University Central Hospital

Enrollment

1,012 participants

Start Date

Feb 10, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • All patients undergoing liver resection

Exclusion Criteria6

  • 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)

Interventions

DRUGenoxaparin 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

DRUGNo intervention

No preoperative thromboprophylaxis.


Locations(7)

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

University Hospital of North Norway

Tromsø, Norway

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NCT04731558


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