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Heparin Like Effect in Acute Variceal Bleeding

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ClinicalTrials.gov Identifier: NCT04111120
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Madhumita Premkumar, Postgraduate Institute of Medical Education and Research

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.


Condition or disease Intervention/treatment
Coagulation Disorder Cirrhosis, Liver Variceal Hemorrhage Diagnostic Test: SONOCLOT, coagulation factor assays for VIII/X, XIII, TPA/ PAI

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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Coagulation Profile and Role of Endogenous Heparinoids in SIRS and Sepsis in Acute Variceal Bleeding in Cirrhosis
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Cirrhosis

Group/Cohort Intervention/treatment
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
Coagulation assessment using heparinase treated SONOCLOT

Cirrhosis without Bleeding
Control group of 25 subjects
Diagnostic Test: SONOCLOT, coagulation factor assays for VIII/X, XIII, TPA/ PAI
Coagulation assessment using heparinase treated SONOCLOT




Primary Outcome Measures :
  1. Generation of Endogenous Heparinoids [ Time Frame: 7 days ]
    Change in SONOCLOT values- global and heparinase treated

  2. Change in plasma levels of Specific Coagulation Factors -VIII, X, XIII, TPA and PAI [ Time Frame: 7 days ]
    Specific factor assessment


Secondary Outcome Measures :
  1. Correlation of sonoclot parameters- ACT, PF and Peak amplitude in predicting blood product utilization [ Time Frame: 7 Days ]
    blood transfusion requirements


Biospecimen Retention:   Samples Without DNA
plasma samples will be stored for coagulation factor assays


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Cirrhosis with acute variceal bleeding
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111120


Contacts
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Contact: Madhumita Premkumar, MD DM 01722756344 drmadhumitap@gmail.com

Locations
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India
Postgraduate Institute of Medical Education and Research Recruiting
Chandigarh, Choose Any State/Province, India, 160012
Contact: Madhumita Premkumar         
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
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Study Chair: RK Dhiman, MD DM Postgraduate Institute of Medical Education and Research
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Responsible Party: Madhumita Premkumar, Assistant Professor, Department of Hepatology, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT04111120    
Other Study ID Numbers: INT/IEC/2019/001615
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Madhumita Premkumar, Postgraduate Institute of Medical Education and Research:
thromboelastography
variceal bleeding
Additional relevant MeSH terms:
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Liver Cirrhosis
Hemostatic Disorders
Blood Coagulation Disorders
Hemorrhage
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders