Global Coagulation Assessment in Cirrhosis and ACLF

Study Overview
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Brief Summary
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Background: Patients with cirrhosis and acute-on-chronic liver failure (ACLF) may have bleeding complications which can lead to increased mortality. Standard coagulation tests (SCTs) like prothrombin time, platelet count and activated partial thromboplastin do not accurately depict in vivo coagulation profile. Point-of-care viscoelastic coagulation testing devices like thrombo-elastography (TEG) and Sonoclot may be better for guiding patient management. Methods: This prospective observational study compared and validated the point of care (POC) tests and SCTs in 70, 72 and 25 persons with ACLF, decompensated cirrhosis and healthy controls respectively.

Official Title
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Clinical Validation of the Use of Global Coagulation Tests Like Thromboelastography and Sonoclot in Liver Disease - A Prospective Observational Study.

Conditions
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Acute-On-Chronic Liver Failure, Cirrhosis, Liver

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with Acute on Chronic Liver Failure All patients with cirrhosis of Liver Exclusion Criteria: Recent blood or blood component transfusion in last 2 weeks HIV infection Antiplatelet, anticoagulant or antifibrinolytic therapy Patients on Dialysis Pregnant females Active malignancy in last 5 years Chronic heart failure Chronic pulmonary disease End stage renal disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute on Chronic Liver Failure<br>All patients of Acute on chronic liver failure according to CANONIC definition, aged more than 18 years were included. Sonoclot, TEG and conventional coagulation tests were done at baseline and at 72 hours. In case of clinically evident bleeding, Point of care tests were repeated to check for changes. | |
| Cirrhosis of Liver<br>All patients with cirrhosis of liver with age more than 18 years were included. Sonoclot, TEG and conventional coagulation tests were done at baseline and at 72 hours. In case of clinically evident bleeding, Point of care tests were repeated to check for changes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of TEG and Sonoclot | To clinically validate the comparibility of results obtained from the TEG and Sonoclot instruments | Day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Point of care test with standard coagulation tests | To investigate whether variables from TEG or Sonoclot analyses correlated with Standard Coagulation Tests | Day 3 | 
| Correlation of Point of care tests with bleeding event | To assess whether a coagulation defect on TEG or Sonoclot predicts a bleeding event or not. | Day 28 | 
| Correlation of Point of care tests with mortality | To assess whether a coagulation defect on TEG or Sonoclot predicts mortality | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sonoclot, Thromboelastography, RoTEM