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

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches to preventing blood clots in patients having part of their liver surgically removed — giving a blood-thinning injection before the operation versus after. **You may be eligible if...** - You are scheduled to have a liver resection (partial removal of the liver) - You are 18 years of age or older - You are able to give written consent **You may NOT be eligible if...** - You have been taking blood-thinning medications (such as heparin, warfarin, or blood thinners like Xarelto or Eliquis) in the past month - Your surgery is an emergency (for trauma or infection) - You have an allergy or medical reason that prevents you from taking the planned blood-thinning injection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

View Full Details on ClinicalTrials.gov

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NCT04731558


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