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Completed

NCT Number: NCT04332484

Global Coagulation Assessment in Cirrhosis and ACLF

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.

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Key information

Conditions

Acute-On-Chronic Liver Failure Cirrhosis, Liver Digestive System Diseases Fibrosis Hepatic Insufficiency Liver Cirrhosis Liver Diseases Liver Failure Liver Failure, Acute Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

PGIMER

Chandigarh, 160012, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Validation of TEG and Sonoclot

    Time frame: Day 3

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

Secondary outcomes

  1. Correlation of Point of care test with standard coagulation tests

    Time frame: Day 3

    To investigate whether variables from TEG or Sonoclot analyses correlated with Standard Coagulation Tests

  2. Correlation of Point of care tests with bleeding event

    Time frame: Day 28

    To assess whether a coagulation defect on TEG or Sonoclot predicts a bleeding event or not.

  3. Correlation of Point of care tests with mortality

    Time frame: 28 days

    To assess whether a coagulation defect on TEG or Sonoclot predicts mortality

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 2, 2020
Registry last updated
Apr 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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