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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

114 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-01

Study Completion Date

2016-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute on Chronic Liver Failure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Decompensated Chronic Liver Disease

Decompensated Chronic Liver Disease patients will be enrol

Sonoclot/TEG test

Intervention Type OTHER

The Sonoclot/TEG test will be done at the study time points. Within 12 hours of presentation in the emergency department, at 72 hours, and at 7 days, or when the patient meets the study criteria for suspected or proven sepsis

Healthy Controls

Healthy Controls will be enrol

Sonoclot/TEG test

Intervention Type OTHER

The Sonoclot/TEG test will be done at the study time points. Within 12 hours of presentation in the emergency department, at 72 hours, and at 7 days, or when the patient meets the study criteria for suspected or proven sepsis

Interventions

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Sonoclot/TEG test

The Sonoclot/TEG test will be done at the study time points. Within 12 hours of presentation in the emergency department, at 72 hours, and at 7 days, or when the patient meets the study criteria for suspected or proven sepsis

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes