Global Coagulation Assessment in Cirrhosis and ACLF

Cirrhosis, Liver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04332484
• Other study ID #: 586
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: August 31, 2019

Study information

• Verified date: April 2020
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute-On-Chronic Liver Failure
• Cirrhosis, Liver
• End Stage Liver Disease
• Fibrosis
• Liver Cirrhosis
• Liver Failure

Locations

Country	Name	City	State
India	PGIMER	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of TEG and Sonoclot	To clinically validate the comparibility of results obtained from the TEG and Sonoclot instruments	Day 3
Secondary	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
Secondary	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
Secondary	Correlation of Point of care tests with mortality	To assess whether a coagulation defect on TEG or Sonoclot predicts mortality	28 days