Global Coagulation Assessment in Cirrhosis and ACLF

Completed

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

• Registration Number: NCT04332484
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31
• Study First Submitted: 2020-03-30
• Status Verified: 2020-04
• Study First Submitted QC: 2020-04-01
• Last Update Submitted: 2020-04-01
• Study First Posted: 2020-04-02
• Last Update Posted: 2020-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validation of TEG and Sonoclot	Day 3	To clinically validate the comparibility of results obtained from the TEG and Sonoclot instruments

Secondary Outcome Measures

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

Trial Locations

Locations (1)

PGIMER; 🇮🇳 Chandigarh, India