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Background: Patients with cirrhosis and acute-on-chronic liver failure (ACLF) may have bleeding complications which can lead to increased mortality. Standard coagulation tests (SCTs) like prothrombin time, platelet count and activated partial thromboplastin do not accurately depict in vivo coagulation profile. Point-of-care viscoelastic coagulation testing devices like thrombo-elastography (TEG) and Sonoclot may be better for guiding patient management.
Methods: This prospective observational study compared and validated the point of care (POC) tests and SCTs in 70, 72 and 25 persons with ACLF, decompensated cirrhosis and healthy controls respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute on Chronic Liver Failure | All patients of Acute on chronic liver failure according to CANONIC definition, aged more than 18 years were included. Sonoclot, TEG and conventional coagulation tests were done at baseline and at 72 hours. In case of clinically evident bleeding, Point of care tests were repeated to check for changes. | ||
| Cirrhosis of Liver | All patients with cirrhosis of liver with age more than 18 years were included. Sonoclot, TEG and conventional coagulation tests were done at baseline and at 72 hours. In case of clinically evident bleeding, Point of care tests were repeated to check for changes. |
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| Measure | Description | Time Frame |
|---|---|---|
| Validation of TEG and Sonoclot | To clinically validate the comparibility of results obtained from the TEG and Sonoclot instruments | Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of Point of care test with standard coagulation tests | To investigate whether variables from TEG or Sonoclot analyses correlated with Standard Coagulation Tests | Day 3 |
| Correlation of Point of care tests with bleeding event |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive patients of ACLF, Cirrhosis of any etiology and Healthy controls were prospectively enrolled between January 2018 and August 2019.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PGIMER | Chandigarh | 160012 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34007803 | Derived | Premkumar M, Mehtani R, Divyaveer S, Kajal K, Kulkarni AV, Ahmed S, Kaur H, Kaur H, Dhiman R, Duseja A, De A. Clinical Validation of Global Coagulation Tests to Guide Blood Component Transfusions in Cirrhosis and ACLF. J Clin Transl Hepatol. 2021 Apr 28;9(2):210-219. doi: 10.14218/JCTH.2020.00121. Epub 2021 Feb 18. |
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| ID | Term |
|---|---|
| D065290 | Acute-On-Chronic Liver Failure |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D017114 | Liver Failure, Acute |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
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To assess whether a coagulation defect on TEG or Sonoclot predicts a bleeding event or not.
| Day 28 |
| Correlation of Point of care tests with mortality | To assess whether a coagulation defect on TEG or Sonoclot predicts mortality | 28 days |
| D004066 |
| Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |