Heparin Like Effect in Acute Variceal Bleeding

• Conditions: Coagulation Disorder; Cirrhosis, Liver; Variceal Hemorrhage
• Interventions: Diagnostic Test: SONOCLOT, coagulation factor assays for VIII/X, XIII, TPA/ PAI

• Registration Number: NCT04111120
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-25
• Study First Submitted QC: 2019-09-28
• Study First Posted: 2019-10-01
• Study Start: 2019-11-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-26
• Last Update Posted: 2021-09-28
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cirrhosis with variceal bleeding	SONOCLOT, coagulation factor assays for VIII/X, XIII, TPA/ PAI	Coagulation factor assays and heparinase treated SONOCLOT at Days 0,3, and 7
Cirrhosis without Bleeding	SONOCLOT, coagulation factor assays for VIII/X, XIII, TPA/ PAI	Control group of 25 subjects

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Correlation of sonoclot parameters- ACT, PF and Peak amplitude in predicting blood product utilization	7 Days	blood transfusion requirements

Trial Locations

Locations (1)

Postgraduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, Choose Any State/Province, India