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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary:
Sponsor: Institute of Liver and Biliary Sciences, India

Current Primary Outcome: 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. [ Time Frame: 0 day, 3 day & 7 day after admission. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Utility of sonoclot/ TEG in predicting blood product utilization. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 0 day, 3 day & 7 day after admission. ]
  • Effect of sepsis on the haematopoietic response of patients with Acute on Chronic Liver Failure. [ Time Frame: 0 day, 3 day & 7 day after admission. ]
    Measurement of reticulocyte count, and peripheral amear- presence of toxic granules.


Original Secondary Outcome: Same as current

Information By: Institute of Liver and Biliary Sciences, India

Dates:
Date Received: November 18, 2014
Date Started: June 2014
Date Completion:
Last Updated: August 17, 2016
Last Verified: April 2016