Clinical trial NCT04731558: Pre- Vs Postoperative Thromboprophylaxis for Liver Resection
Official title: Pre- Vs Postoperative Thromboprophylaxis for Liver Resection - a Prospective, Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Liver Cancer
Surgery
Thrombosis, Deep Vein
Embolism, Pulmonary
Bleeding
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Academy of Finland
name: The Finnish Medical Association
First posted: 2021-02-01
Enrollment: 1012
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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)

Primary outcomes:
measure: Venous thromboembolisms
timeFrame: within 30 days from liver resection
Secondary outcomes:
measure: Posthepatectomy haemorrhage
timeFrame: within 30 days from liver resection
measure: Postoperative complications
timeFrame: within 30 days from liver resection
measure: Length of postoperative hospital stay
timeFrame: within 30 days from liver resection
measure: Blood transfusion
timeFrame: during and within 30 days from liver resection
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Tromsø
country: Norway
facility: University Hospital of North Norway
Study officials:
References: