Global Coagulation Assessment in Cirrhosis and ACLF

Post Graduate Institute of Medical Education and Research, Chandigarh

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT04332484

586

Details and patient eligibility

About

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.

Enrollment: 142 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

142 participants in 2 patient groups

Acute on Chronic Liver Failure

Description:

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

Description:

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.