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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

Tracking Information
First Submitted Date September 25, 2019
First Posted Date October 1, 2019
Last Update Posted Date January 27, 2020
Actual Study Start Date November 1, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 22, 2020)
  • Generation of Endogenous Heparinoids [ Time Frame: 7 days ]
    Change in SONOCLOT values- global and heparinase treated
  • Change in plasma levels of Specific Coagulation Factors -VIII, X, XIII, TPA and PAI [ Time Frame: 7 days ]
    Specific factor assessment
Original Primary Outcome Measures
 (submitted: September 28, 2019)
  • Generation of Endogenous Heparinoids [ Time Frame: 7 days ]
    Change in SONOCLOT values- global and heparinase treated
  • Change in plasma levels of Specific Coagulation Factors -VIII, X, XIII, TPA and PAI [ Time Frame: 7 days ]
Change History
Current Secondary Outcome Measures
 (submitted: January 22, 2020)
Correlation of sonoclot parameters- ACT, PF and Peak amplitude in predicting blood product utilization [ Time Frame: 7 Days ]
blood transfusion requirements
Original Secondary Outcome Measures
 (submitted: September 28, 2019)
  • Correlation of sonoclot parameters- ACT, PF and Peak amplitude in predicting blood product utilization [ Time Frame: 7 Days ]
  • New onset of sepsis event [ Time Frame: 7 Days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Heparin Like Effect in Acute Variceal Bleeding
Official Title Assessment of Coagulation Profile and Role of Endogenous Heparinoids in SIRS and Sepsis in Acute Variceal Bleeding in Cirrhosis
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
plasma samples will be stored for coagulation factor assays
Sampling Method Non-Probability Sample
Study Population Cirrhosis with acute variceal bleeding
Condition
  • Coagulation Disorder
  • Cirrhosis, Liver
  • Variceal Hemorrhage
Intervention Diagnostic Test: SONOCLOT, coagulation factor assays for VIII/X, XIII, TPA/ PAI
Coagulation assessment using heparinase treated SONOCLOT
Study Groups/Cohorts
  • Cirrhosis with variceal bleeding
    Coagulation factor assays and heparinase treated SONOCLOT at Days 0,3, and 7
    Intervention: Diagnostic Test: SONOCLOT, coagulation factor assays for VIII/X, XIII, TPA/ PAI
  • Cirrhosis without Bleeding
    Control group of 25 subjects
    Intervention: Diagnostic Test: SONOCLOT, coagulation factor assays for VIII/X, XIII, TPA/ PAI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 28, 2019)
75
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Madhumita Premkumar, MD DM 01722756344 drmadhumitap@gmail.com
Listed Location Countries India
Removed Location Countries  
 
Administrative Information
NCT Number NCT04111120
Other Study ID Numbers INT/IEC/2019/001615
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Madhumita Premkumar, Postgraduate Institute of Medical Education and Research
Study Sponsor Postgraduate Institute of Medical Education and Research
Collaborators Not Provided
Investigators
Study Chair: RK Dhiman, MD DM Postgraduate Institute of Medical Education and Research
PRS Account Postgraduate Institute of Medical Education and Research
Verification Date January 2020