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Heparin Like Effect in Acute Variceal Bleeding

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04111120
Enrollment
75
Registered
2019-10-01
Start date
2019-11-01
Completion date
2021-12-31
Last updated
2021-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Liver, Coagulation Disorder, Variceal Hemorrhage

Keywords

thromboelastography, variceal bleeding

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.

Interventions

DIAGNOSTIC_TESTSONOCLOT, coagulation factor assays for VIII/X, XIII, TPA/ PAI

Coagulation assessment using heparinase treated SONOCLOT

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Generation of Endogenous Heparinoids7 daysChange in SONOCLOT values- global and heparinase treated
Change in plasma levels of Specific Coagulation Factors -VIII, X, XIII, TPA and PAI7 daysSpecific factor assessment

Secondary

MeasureTime frameDescription
Correlation of sonoclot parameters- ACT, PF and Peak amplitude in predicting blood product utilization7 Daysblood transfusion requirements

Countries

India

Contacts

Primary ContactMadhumita Premkumar, MD DM
drmadhumitap@gmail.com01722756344

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026