In vitro pro- and anticoagulant drug effect and hepatobiliary surgery
Research type
Research Study
Full title
The efficacy of pro- and anticoagulant therapy in plasma of patients undergoing hepatobiliary surgery
IRAS ID
220287
Contact name
William Bernal
Contact email
Sponsor organisation
Kings College Hospital NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
The liver is central to the process of 'haemostasis', the process that enables blood to clot. Amongst its important functions are the synthesis of both pro- and anti-coagulant substances. Major hepatobiliary surgery is associated with complications that may include both intraoperative bleeding and postoperative thromboembolism, including deep vein thrombosis and pulmonary embolism. These complications may result in both morbidity and mortality; their risk increases with the extent of the procedure. Pre-operative prediction is difficult as risk of bleeding and thrombosis is not well reflected by conventional hemostasis tests such as the prothrombin time and platelet count. More advanced hemostasis testing, for example by newer assays such as 'thrombomodulin-modified thrombin generation' testing, is consistent with a post-operative hyper-coagulable state in many cases. Hemostatic profiles during and after liver surgery have been recently studied in detail using these assays. However, little clinical is available on the efficacy and safety of pro- and anti-hemostatic drugs used in patients identified as being at risk.
We aim to assess the in vitro efficacy of both pro- and anticoagulant drugs by comparing thrombin generation curves generated in plasma from blood samples taken from patients during and after liver and hepatobiliary surgery and with thrombin generation curves generated in the plasma of healthy volunteers. Various pro- and anti-coagulant drugs will be added to these plasma samples in vitro. The change in parameters of the thrombin generation curve after addition of pro- or anticoagulant drug will be evaluated. This study may help identify those drugs most effective in this setting and guide their dosage in patients during and after liver surgery.REC name
London - Westminster Research Ethics Committee
REC reference
17/LO/0527
Date of REC Opinion
5 Apr 2017
REC opinion
Favourable Opinion