Global Coagulation Assessment in Cirrhosis and ACLF

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

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.

Study Overview

• Status: Completed
• Conditions: Acute-On-Chronic Liver Failure; Cirrhosis, Liver

• Study Type: Observational
• Enrollment (Actual): 142

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160012
    • PGIMER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients of ACLF, Cirrhosis of any etiology and Healthy controls were prospectively enrolled between January 2018 and August 2019.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Acute on Chronic Liver Failure; 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; 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?

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

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research

Publications and helpful links

General Publications

• Premkumar M, Mehtani R, Divyaveer S, Kajal K, Kulkarni AV, Ahmed S, Kaur H, Kaur H, Dhiman R, Duseja A, De A. Clinical Validation of Global Coagulation Tests to Guide Blood Component Transfusions in Cirrhosis and ACLF. J Clin Transl Hepatol. 2021 Apr 28;9(2):210-219. doi: 10.14218/JCTH.2020.00121. Epub 2021 Feb 18.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): August 31, 2019
• Study Completion (ACTUAL): August 31, 2019

Study Registration Dates

• First Submitted: March 30, 2020
• First Submitted That Met QC Criteria: April 1, 2020
• First Posted (ACTUAL): April 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 2, 2020
• Last Update Submitted That Met QC Criteria: April 1, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Thromboelastography; Sonoclot; RoTEM
• Additional Relevant MeSH Terms: Digestive System Diseases; Hepatic Insufficiency; Pathologic Processes; Liver Diseases; Liver Failure, Acute; End Stage Liver Disease; Fibrosis; Liver Failure; Acute-On-Chronic Liver Failure; Liver Cirrhosis
• Other Study ID Numbers: 586

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No