This is a prospective observational study of 100 patients undergoing liver transplantation at a single centre. Thrombin generation and kinetics will be assessed using a novel point-of-care device, and compared to conventional measures of hemostasis as well as viscoelastic tests to pinpoint specific coagulation deficits and identify potential therapeutic targets. The clinical course of patients will be followed for major bleeding and transfusion outcomes.
Liver transplantation is the only curative option for end stage liver disease, but is associated with high morbidity and mortality. End stage liver disease is known to be accompanied by dysregulated coagulation, which is further exacerbated in the immediate perioperative period by transplantation, leading to both coagulopathic bleeding and thrombosis. Altered thrombin generation is thought to play a key role in the predisposition of these patients for both severe coagulopathic hemorrhage and life-threatening thromboembolic complications. Despite this, thrombin generation during the immediate transplant period in patients with end-stage liver disease is poorly characterized, in part because it is not well reflected by conventional measures of coagulation. This study aims to characterize changes in thrombin generation capacity pre, intra- and post-transplant utilizing a novel point-of-care thrombin generation assay. Other specific aims of the study are to identify risk factors for patients with impaired thrombin generation and will assess the association of impaired thrombin generation with overall clinical bleeding risk. The overarching goal of this work is to develop a point-of-care-testing guided algorithm addressing dysregulated thrombin formation that improves coagulation management without increasing the risk of thromboembolic complications. Ultimately, this line of research will improve the outcomes of liver transplantation.
Study Type
OBSERVATIONAL
Enrollment
100
Toronto General Hospital - University Health Network
Toronto, Ontario, Canada
RECRUITINGThrombin Generation - Endogenous Thrombin Potential (nM*min)
The change in thrombin generation will be measured in patients undergoing liver transplantation, as assessed through the Endogenous Thrombin Potential (nM\*min)
Time frame: The pattern of change in thrombin generation will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively
Thrombin Generation - Lag Time (Seconds)
The change in thrombin generation will be measured in patients undergoing liver transplantation as assessed by the Lag Time (Seconds)
Time frame: The pattern of change in thrombin generation will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively
Thrombin Generation - Time to Peak (Seconds)
The change in thrombin generation will be measured in patients undergoing liver transplantation by the Time to Peak (Seconds)
Time frame: The pattern of change in thrombin generation will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively
Thrombin Generation - Peak Height (nM)
The change in thrombin generation will be measured in patients undergoing liver transplantation by the Peak Height (nM)
Time frame: The pattern of change in thrombin generation will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively
Conventional Hemostatic Tests - Platelet Count
The platelet count from the complete blood count in x10\^9/L
Time frame: The pattern of change will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively
Conventional Hemostatic Tests - INR
The international normalized ratio (INR) in seconds
Time frame: The pattern of change will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively
Conventional Hemostatic Tests - aPTT
The activated partial thromboplastin time (aPTT) in seconds
Time frame: The pattern of change will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively
Conventional Hemostatic Tests - Fibrinogen Level
The Clauss Fibrinogen level in g/L
Time frame: The pattern of change will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively
Viscoelastic Testing
Rotational thromboelastometry (ROTEM)
Time frame: The pattern of change will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively
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