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Clinical Trials/NCT04111120
NCT04111120
Unknown
Not Applicable

Assessment of Coagulation Profile and Role of Endogenous Heparinoids in SIRS and Sepsis in Acute Variceal Bleeding in Cirrhosis

Post Graduate Institute of Medical Education and Research, Chandigarh1 site in 1 country75 target enrollmentNovember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coagulation Disorder
Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Enrollment
75
Locations
1
Primary Endpoint
Generation of Endogenous Heparinoids
Last Updated
4 years ago

Overview

Brief Summary

This study attempts to clarify the pathophysiology of haemostasis 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 acute variceal bleeding in cirrhosis, to correctly identify the type and optimal quantity of blood product requirement in at risk patients.

Thromboelastography (TEG) /Sonoclot has 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 cirrhosis who present with acute variceal bleeding, 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 thrombin generation response swill be assessed. Thus the effect of sepsis on the progression and outcome of coagulopathy in patients with acute variceal bleeding will be studied.

Registry
clinicaltrials.gov
Start Date
November 1, 2019
End Date
December 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Responsible Party
Principal Investigator
Principal Investigator

Madhumita Premkumar

Assistant Professor, Department of Hepatology

Post Graduate Institute of Medical Education and Research, Chandigarh

Eligibility Criteria

Inclusion Criteria

  • Age 18-65 years
  • Cirrhosis with acute variceal bleeding.

Exclusion Criteria

  • Patients with evidence of sepsis at presentation.
  • Current therapy: Recent blood or blood component transfusion in the last 2 weeks.
  • HIV positive/ AIDS patients
  • Patients requiring antiplatelet 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

Outcomes

Primary Outcomes

Generation of Endogenous Heparinoids

Time Frame: 7 days

Change in SONOCLOT values- global and heparinase treated

Change in plasma levels of Specific Coagulation Factors -VIII, X, XIII, TPA and PAI

Time Frame: 7 days

Specific factor assessment

Secondary Outcomes

  • Correlation of sonoclot parameters- ACT, PF and Peak amplitude in predicting blood product utilization(7 Days)

Study Sites (1)

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