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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,012
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
No preoperative thromboprophylaxis.
Helsinki University Hospital
Helsinki, Finland
RECRUITINGKuopio University Hospital
Kuopio, Finland
RECRUITINGOulu University Hospital
Oulu, Finland
NOT_YET_RECRUITINGTampere University Hospital
Tampere, Finland
RECRUITINGTurku University Hospital
Turku, Finland
NOT_YET_RECRUITINGOslo University Hospital
Oslo, Norway
RECRUITINGUniversity Hospital of North Norway
Tromsø, Norway
RECRUITINGVenous thromboembolisms
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
Time frame: within 30 days from liver resection
Posthepatectomy haemorrhage
Number of patients with posthepatectomy haemorrhage, any grade in ISGLS classification
Time frame: within 30 days from liver resection
Postoperative complications
Comprehensive Complication Index - score
Time frame: within 30 days from liver resection
Length of postoperative hospital stay
Length of postoperative hospital stay, days
Time frame: within 30 days from liver resection
Blood transfusion
Total amount of transfused red blood cells, units
Time frame: during and within 30 days from liver resection
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