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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cirrhosis with variceal bleeding | Coagulation factor assays and heparinase treated SONOCLOT at Days 0,3, and 7 |
| |
| Cirrhosis without Bleeding | Control group of 25 subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SONOCLOT, coagulation factor assays for VIII/X, XIII, TPA/ PAI | Diagnostic Test | Coagulation assessment using heparinase treated SONOCLOT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of sonoclot parameters- ACT, PF and Peak amplitude in predicting blood product utilization | blood transfusion requirements | 7 Days |
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Inclusion Criteria:
Exclusion Criteria:
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Cirrhosis with acute variceal bleeding
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Madhumita Premkumar, MD DM | Contact | 01722756344 | drmadhumitap@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| RK Dhiman, MD DM | Post Graduate Institute of Medical Education and Research, Chandigarh | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Postgraduate Institute of Medical Education and Research | Recruiting | Chandigarh | Choose Any State/Province | 160012 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35984611 | Derived | 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. |
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| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
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plasma samples will be stored for coagulation factor assays
| D006425 |
| Hemic and Lymphatic Diseases |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |