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

Acute on Chronic Liver Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02307409
• Other study ID #: ILBS-SIRS-01
• Status: Completed
• Phase: N/A
• First received: November 18, 2014
• Last updated: February 7, 2018
• Start date: June 1, 2014
• Est. completion date: August 1, 2016

Study information

• Verified date: April 2016
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: August 1, 2016
• Est. primary completion date: April 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute on Chronic Liver Failure
• Acute-On-Chronic Liver Failure
• End Stage Liver Disease
• Liver Failure

Intervention

Other:
• 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

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Utility of sonoclot/ TEG in predicting blood product utilization.	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%.	0 day, 3 day & 7 day after admission.
Secondary	Sonoclot/TEG result indicating hypocoagulability correlates with the patient's tendency to bleed in ACLF.	Reporting of number and site of bleed- skin, mucosa, urine, GI tract, CNS etc.	0 day, 3 day & 7 day after admission.
Secondary	Changes in baseline coagulation profile can predict development of sepsis in patients of ACLF.	Correlation of PT/INR with TEG parameters and positive blood or urine culture.	0 day, 3 day & 7 day after admission.
Secondary	Coagulation dysfunction (prothrombotic and anticoagulant tendencies) in patients with ACLF with or without evidence of sepsis.		0 day, 3 day & 7 day after admission.
Secondary	Effect of sepsis on the haematopoietic response of patients with Acute on Chronic Liver Failure.	Measurement of reticulocyte count, and peripheral amear- presence of toxic granules.	0 day, 3 day & 7 day after admission.