Global Coagulation Assessment in Cirrhosis and ACLF

NCT04332484 | Completed

• 1 other identifier: 586
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute-On-Chronic Liver Failure; Cirrhosis, Liver

Keywords

Sonoclot; Thromboelastography; RoTEM

Outcome Measures

Primary Outcomes (1)

• Validation of TEG and Sonoclot

  To clinically validate the comparibility of results obtained from the TEG and Sonoclot instruments

  Day 3

Secondary Outcomes (3)

• Correlation of Point of care test with standard coagulation tests

  Day 3

• Correlation of Point of care tests with bleeding event

  Day 28

• Correlation of Point of care tests with mortality

  28 days

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• All patients with Acute on Chronic Liver Failure
• All patients with cirrhosis of Liver

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

PGIMER

Chandigarh, 160012, India

Location

Related Publications (1)

• 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.

  PMID: 34007803 DERIVED

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 2, 2020
• Study Start: January 1, 2018
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: April 2, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)