Stopped: Funding withdrawn by commercial partner before recruitment phase (change of company ownership).
Severe coagulopathy and operative bleeding are common in liver and multivisceral transplant recipients. This is related to reduced synthesis and function of clotting proteins in end-stage liver disease, thrombocytopaenia, thrombocytopathy, accelerated fibrinolysis, portal hypertension, inflammatory adhesions and intraoperative hemodilution. A pro-coagulant state is also a common finding in both groups, sometimes associated with fatal thromboembolism, and the balance between anti- and pro-coagulant effects is easily disrupted by intraoperative events. Use of point-of-care intraoperative viscoelastic testing, capable of discriminating between various potential causes of coagulopathy and of identifying some hypercoagulable states, is now routine in this setting. This has been shown to guide treatment faster and more reliably than standard laboratory screening tests. However, traditional viscoelastic tests based on a pin-and-cup arrangement are sensitive to technical error, movement and physical clot disruption, and the validity of measurements is highly dependent on operator training. A newer method (TEG® 6S) based on light reflection from a blood meniscus reduces scope for operator error but remains sensitive to movement. Measurement of ultrasonic resonance (or 'sonic estimation of elasticity via resonance \[SEER\] sonorheometry') using the Quantra® analyzer surgery appears to minimize these problems in studies performed in healthy volunteers, in spinal surgery and in both elective and urgent cardiac procedures. Pilot testing in the latter group suggests it may also differentiate qualitatively between fibrinogen and platelet deficiency, but the range of intrinsic coagulation disturbances in this context is limited. This study proposes to assess the validity of the Quantra® analyzer in a population with more extreme coagulopathy, including severe fibrinolysis, and recognized thrombophilic states.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Quantra® parameters' correlation with conventional laboratory tests (including thrombin generation), TEG® 6S parameters and clinical bleeding scores.
Timeframe: 1 year