Bleeding, Embolism, Pulmonary, Liver Cancer, Surgery, Thrombosis, Deep Vein
Conditions
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.
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.
Sponsors
Academy of Finland
The Finnish Medical Association
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Posthepatectomy haemorrhage | within 30 days from liver resection | Number of patients with posthepatectomy haemorrhage, any grade in ISGLS classification |
| Postoperative complications | within 30 days from liver resection | Comprehensive Complication Index - score |
| Length of postoperative hospital stay | within 30 days from liver resection | Length of postoperative hospital stay, days |
| Blood transfusion | during and within 30 days from liver resection | Total amount of transfused red blood cells, units |
Countries
Finland, Norway
Contacts
Primary ContactVille Sallinen, MD, PhD
Outcome results
None listed