Clinical trial NCT04111120: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coagulation Disorder
Cirrhosis, Liver
Variceal Hemorrhage
Keywords: thromboelastography
variceal bleeding
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2019-10-01
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cirrhosis with acute 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.


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

Primary outcomes:
measure: Generation of Endogenous Heparinoids
timeFrame: 7 days
measure: Change in plasma levels of Specific Coagulation Factors -VIII, X, XIII, TPA and PAI
timeFrame: 7 days
Secondary outcomes:
measure: Correlation of sonoclot parameters- ACT, PF and Peak amplitude in predicting blood product utilization
timeFrame: 7 Days
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education and Research
state: Choose Any State/Province
Study officials:
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: RK Dhiman, MD DM
role: STUDY_CHAIR
References:
citation: 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.