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Completed

NCT Number: NCT02307409

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sonoclot/TEG test

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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%.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 4, 2014
Registry last updated
Feb 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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