Heparin Like Effect in Acute Variceal Bleeding

Study 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.

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

Conditions
-----------------
Coagulation Disorder, Cirrhosis, Liver, Variceal Hemorrhage

Intervention / Treatment
-----------------
* Diagnostic Test: SONOCLOT, coagulation factor assays for VIII/X, XIII, TPA/ PAI


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cirrhosis with variceal bleeding<br>Coagulation factor assays and heparinase treated SONOCLOT at Days 0,3, and 7 | Diagnostic Test: SONOCLOT, coagulation factor assays for VIII/X, XIII, TPA/ PAI<br>* Coagulation assessment using heparinase treated SONOCLOT<br>|
| Cirrhosis without Bleeding<br>Control group of 25 subjects | Diagnostic Test: SONOCLOT, coagulation factor assays for VIII/X, XIII, TPA/ PAI<br>* Coagulation assessment using heparinase treated SONOCLOT<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generation of Endogenous Heparinoids | Change in SONOCLOT values- global and heparinase treated | 7 days | 
| Change in plasma levels of Specific Coagulation Factors -VIII, X, XIII, TPA and PAI | Specific factor assessment | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of sonoclot parameters- ACT, PF and Peak amplitude in predicting blood product utilization | blood transfusion requirements | 7 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thromboelastography, variceal bleeding