New treatment for cardiac abnormalities in cirrhosis

Completed

• Conditions: Other and unspecified cirrhosis ofliver,

• Registration Number: CTRI/2018/02/012230
• Lead Sponsor: Institute of liver and Biliary Sciences

Brief Summary

Dynamic coagulation derangements, measured by thromboelastography, determine the likelihood of bleeding, sepsis and mortality in ACLF (Acute on Chronic Liver Failure).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-06
• Study Completion: 2016-01-08
• Last Update Posted: 2018-01-12

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1)Age 18-65 years 2)ACLF (Acute on Chronic Liver Failure), as diagnosed by APASL (Asian Pacific association of Study of Liver Disease) criteria mentioned above.

Exclusion Criteria

• 1)Patients with evidence of sepsis at presentation.
• 2)Current therapy: Recent blood or blood component transfusion in the last 2 days.
• 3)HIV positive/ AIDS patients 4)Patients requiring anti platelet therapy, 5)Renal insufficiency requiring dialysis 6)Active malignancy within the last 5 years 7)Patient with other neurological disease and metabolic disorders, unbalanced heart failure and/or respiratory failure or end-stage renal disease 8)Administration of anticoagulants, antifibrinolytics, 9)Not willing to participate in the study Pregnancy.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence and severity of coagulation profile derangement and haematopoietic responses, by sonoclot/ TEG, coagulation and hematological parameters, in acute- on-chronic liver failure with and without systemic inflammatory response.	0 day, 3 day and 7 day after admission

Secondary Outcome Measures

Name	Time	Method
Utility of sonoclot/ TEG in predicting blood product utilization.	0 day, 3 day and 7 day after admission
Sonoclot/TEG result indicating hypocoagulability correlates with the patients tendency to bleed in ACLF	0 day, 3 day and 7 day after admission
Changes in baseline coagulation profile can predict development of sepsis in patients of ACLF.	0 day, 3 day and 7 day after admission
Coagulation dysfunction (prothrombotic and anticoagulant tendencies) in patients with ACLF with or without evidence of sepsis.	0 day, 3 day and 7 day after admission
Effect of sepsis on the haematopoietic response of patients with Acute on Chronic Liver Failure.	0 day, 3 day and 7 day after admission

Trial Locations

Locations (1)

Institute of Liver and Biliary Sciences; 🇮🇳 Delhi, DELHI, India

Institute of Liver and Biliary Sciences

🇮🇳Delhi, DELHI, India

Dr Madhumita

Principal investigator

01146300000

drmadhumitap@gmail.com