Global Coagulation Assessment in Cirrhosis and ACLF

NCT ID: NCT04332484

Last Updated: 2020-04-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 142 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2019-08-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: lead

Responsible Party

Madhumita Premkumar

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

PGIMER

Chandigarh, , India

Countries

India

References

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.

Reference Type: DERIVED

PMID: 34007803 (View on PubMed)

Other Identifiers

586

Identifier Type: -

Identifier Source: org_study_id