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Heparin Like Effect in Acute Variceal Bleeding

NCT04111120 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2021-09-28

No results posted yet for this study

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.

Conditions

  • Coagulation Disorder
  • Cirrhosis, Liver
  • Variceal Hemorrhage

Interventions

DIAGNOSTIC_TEST

SONOCLOT, coagulation factor assays for VIII/X, XIII, TPA/ PAI

Coagulation assessment using heparinase treated SONOCLOT

Sponsors & Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    lead OTHER

Principal Investigators

  • RK Dhiman, MD DM · Post Graduate Institute of Medical Education and Research, Chandigarh

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04111120 on ClinicalTrials.gov