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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04332484

Enrollment

142

Registered

2020-04-02

Start date

2018-01-01

Completion date

2019-08-31

Last updated

2020-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute-On-Chronic Liver Failure, Cirrhosis, Liver

Keywords

Sonoclot, Thromboelastography, RoTEM

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Validation of TEG and Sonoclot	Day 3	To clinically validate the comparibility of results obtained from the TEG and Sonoclot instruments

Secondary

Measure	Time frame	Description
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.
Correlation of Point of care tests with mortality	28 days	To assess whether a coagulation defect on TEG or Sonoclot predicts mortality

Countries

India

Outcome results