Heparin Like Effect in Acute Variceal Bleeding

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-01

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Coagulation Disorder Cirrhosis, Liver Variceal Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cirrhosis with variceal bleeding

Coagulation factor assays and heparinase treated SONOCLOT at Days 0,3, and 7

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

Intervention Type DIAGNOSTIC_TEST

Coagulation assessment using heparinase treated SONOCLOT

Cirrhosis without Bleeding

Control group of 25 subjects

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

Intervention Type DIAGNOSTIC_TEST

Coagulation assessment using heparinase treated SONOCLOT

Interventions

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

Coagulation assessment using heparinase treated SONOCLOT

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes