Heparin Like Effect in Acute Variceal Bleeding

Cirrhosis, Liver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04111120
• Other study ID #: INT/IEC/2019/001615
• Status: Recruiting
• Start date: November 1, 2019
• Est. completion date: December 2021

Study information

• Verified date: September 2021
• Source: Postgraduate Institute of Medical Education and Research
• Contact: Madhumita Premkumar, MD DM
• Phone: 01722756344
• Email: drmadhumitap[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Cirrhosis, Liver
• Coagulation Disorder
• Fibrosis
• Hemorrhage
• Hemostatic Disorders
• Liver Cirrhosis
• Variceal Hemorrhage

Intervention

Diagnostic Test:
• SONOCLOT, coagulation factor assays for VIII/X, XIII, TPA/ PAI
Coagulation assessment using heparinase treated SONOCLOT

Locations

Country	Name	City	State
India	Postgraduate Institute of Medical Education and Research	Chandigarh	Choose Any State/Province

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Generation of Endogenous Heparinoids	Change in SONOCLOT values- global and heparinase treated	7 days
Primary	Change in plasma levels of Specific Coagulation Factors -VIII, X, XIII, TPA and PAI	Specific factor assessment	7 days
Secondary	Correlation of sonoclot parameters- ACT, PF and Peak amplitude in predicting blood product utilization	blood transfusion requirements	7 Days