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

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Acute on Chronic Liver Failure

Treatments: Other: Sonoclot/TEG test

Study type: Observational

Funder types: Other

Identifiers

NCT02307409

ILBS-SIRS-01

Details and patient eligibility

About

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.

Enrollment: 114 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

114 participants in 2 patient groups

Decompensated Chronic Liver Disease

Description:

Decompensated Chronic Liver Disease patients will be enrol

Treatment:

Other: Sonoclot/TEG test

Healthy Controls

Description:

Healthy Controls will be enrol

Treatment:

Other: Sonoclot/TEG test