Heparin Like Effect in Acute Variceal Bleeding

NCT04111120 | Unknown

• 1 other identifier: INT/IEC/2019/001615
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Coagulation Disorder; Cirrhosis, Liver; Variceal Hemorrhage

Keywords

thromboelastography; variceal bleeding

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Correlation of sonoclot parameters- ACT, PF and Peak amplitude in predicting blood product utilization

  7 Days

Study Arms (2)

Cirrhosis with variceal bleeding

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

Cirrhosis without Bleeding

Control group of 25 subjects

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

Interventions

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

Coagulation assessment using heparinase treated SONOCLOT

Cirrhosis with variceal bleeding; Cirrhosis without Bleeding

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cirrhosis with acute variceal bleeding

You may qualify if:

• Age 18-65 years
• Cirrhosis with acute variceal bleeding.

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, Choose Any State/Province, 160012, India

RECRUITING

Related Publications (1)

• Premkumar M, Mehtani R, Kulkarni AV, Duseja AK, De A, Taneja S, Singh V, Verma N, Ahluwalia J, Kajal K, Divyaveer S, Roy A, Gandotra A, Kalson N, Kekan K, Kaur H, Kaur H. Association of Heparin-Like Effect, Factor VII/XIII Deficiency and Fibrinolysis with Rebleeding Risk in Cirrhosis with Acute Variceal Bleeding. Dig Dis Sci. 2023 Feb;68(2):497-513. doi: 10.1007/s10620-022-07656-9. Epub 2022 Aug 19.

  PMID: 35984611 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma samples will be stored for coagulation factor assays

MeSH Terms

Conditions

Hemostatic Disorders; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• RK Dhiman, MD DM

  Post Graduate Institute of Medical Education and Research, Chandigarh

  STUDY CHAIR

Central Study Contacts

Madhumita Premkumar, MD DM

CONTACT

01722756344; drmadhumitap@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Hepatology

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: October 1, 2019
• Study Start: November 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

IN (1)