PREPOSTEROUS Liver, v.1.0
Research type
Research Study
Full title
A prospective randomised study to assess the safety and efficacy of PREoperatively initiated versus POSToperatively initiated prevention of thromboembolic complications patients undergoing a LIVER resection (PREPOSTEROUS Liver trial)
IRAS ID
315619
Contact name
Ewen Harrison
Contact email
Sponsor organisation
University of Edinburgh
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
2019-002323-15, EUdraCT
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
Thrombosis prophylaxis for liver surgery can be commenced either before or after the
Thrombosis prophylaxis for liver surgery can be commenced either before or after the surgery. Theoretically preoperative prophylaxis may reduce the number and severity of blood clotting complications, mainly pulmonary embolisms, but on the other side, there may be an increased risk of bleeding. Both these protocols are commonly in use in UK and elsewhere. There is no international consensus on optimal timing of the thrombosis prophylaxis for patients undergoing liver surgery. As far as we know, there are no prospective randomised 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 thrombosis prophylaxis guidelines for abdominal cancer surgery support the preoperative initiation of thrombosis prophylaxis, but these guidelines do not specifically address the increased bleeding risk associated with liver surgery. On the contrary, Dutch guidelines recommend postoperative thrombosis prophylaxis only, because of lack of evidence for preoperative thrombosis prophylaxis. Traditionally, many liver surgery units have been reluctant in using preoperative thrombosis prophylaxis due to the potentially increased risk of bleeding complications. Enhanced Recovery After Surgery (ERAS) Society Guidelines state that there is no evidence of preoperative prophylaxis in liver surgery. Overall, the amount of evidence is scarce and somewhat contradictory in this clinically relevant field. The aim of this study is to compare before surgery (preoperatively) and after surgery (postoperatively) initiated thrombosis prophylaxis regimens in liver surgery in a randomised controlled trial. All the participants will receive the standard 28 days prophylaxis after the surgery. The study does not compare the effects of a specific medication, but rather compares two different protocols using any of the widely available low-molecular-weight heparin products (dalteparin, enoxaparin and tinzaparin) used according to their standard UK accepted indications and doses.REC name
London - Central Research Ethics Committee
REC reference
23/LO/0589
Date of REC Opinion
26 Aug 2023
REC opinion
Further Information Favourable Opinion