Assessment of Coagulation Profile and Haematopoietic Responses in Patients With Acute-on-chronic Liver Failure During Systemic Inflammatory Response (SIRS) and Sepsis

Completed

• Conditions: Acute on Chronic Liver Failure
• Interventions: Other: Sonoclot/TEG test

• Registration Number: NCT02307409
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief Summary

This study attempts to clarify the pathophysiology of haemostasis and haematopoiesis in relation to the evidence of sepsis in liver disease, and compares the accuracy of various available laboratory tests in assessment of these patients. Further research is needed for proper understanding of the influence of sepsis on coagulation disorders in ACLF (Acute on Chronic Liver Failure) patients in particular, to correctly identify the type and optimal quantity of blood product requirement in at risk patients.

Thromboelastography (TEG) /Sonoclot have been proposed as a superior tool to rapidly diagnose and help guide resuscitation with blood products. Secondly, the study of derangement in coagulopathy after the onset of sepsis is of paramount importance because of increased mortality after the onset of sepsis. In the present study, patients with ACLF (Acute on Chronic Liver Failure) without evidence of sepsis on admission will be included in the study cohort, and will undergo a baseline diagnostic workup as described. They will be followed for development of any signs of infection after hospitalization. Then the effect of sepsis on their coagulation and haematopoietic cellular responses will be assessed. Thus the effect of sepsis on the progression and outcome of patients with ACLF (Acute on Chronic Liver Failure) will be studied.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-01
• Study First Submitted: 2014-11-18
• Study First Submitted QC: 2014-12-01
• Study First Posted: 2014-12-04
• Status Verified: 2016-04
• Primary Completion: 2016-04-01
• Study Completion: 2016-08-01
• Last Update Submitted: 2018-02-07
• Last Update Posted: 2018-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Controls	Sonoclot/TEG test	Healthy Controls will be enrol
Decompensated Chronic Liver Disease	Sonoclot/TEG test	Decompensated Chronic Liver Disease patients will be enrol

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 & 7 day after admission.

Secondary Outcome Measures

Name	Time	Method
Utility of sonoclot/ TEG in predicting blood product utilization.	0 day, 3 day & 7 day after admission.	Reporting of blood product usage in 7 days of admission as per TEG R time, K time, Maximum amplitude of curve, angle, lysis at 30%.
Sonoclot/TEG result indicating hypocoagulability correlates with the patient's tendency to bleed in ACLF.	0 day, 3 day & 7 day after admission.	Reporting of number and site of bleed- skin, mucosa, urine, GI tract, CNS etc.
Changes in baseline coagulation profile can predict development of sepsis in patients of ACLF.	0 day, 3 day & 7 day after admission.	Correlation of PT/INR with TEG parameters and positive blood or urine culture.
Coagulation dysfunction (prothrombotic and anticoagulant tendencies) in patients with ACLF with or without evidence of sepsis.	0 day, 3 day & 7 day after admission.
Effect of sepsis on the haematopoietic response of patients with Acute on Chronic Liver Failure.	0 day, 3 day & 7 day after admission.	Measurement of reticulocyte count, and peripheral amear- presence of toxic granules.

Trial Locations

Locations (1)

Institute of Liver & Biliary Sciences; 🇮🇳 New Delhi, Delhi, India