Heparin Like Effect in Acute Variceal Bleeding

Post Graduate Institute of Medical Education and Research, Chandigarh

Status

Unknown

Conditions

Cirrhosis, Liver

Coagulation Disorder

Variceal Hemorrhage

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT04111120

INT/IEC/2019/001615

Details and patient eligibility

About

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.

Enrollment

75 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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