A Comparative Evaluation of TEG Versus ROTEM for Coagulopathy Correction

Study Overview
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Brief Summary
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Studies comparing Thromboelastography or Rotational thromboelastometry versus standard coagulation tests are abundant. Data comparing the two exclusively in a liver intensive care set up is limited. Studies show that TEG and ROTEM cannot be used interchangeably in trauma, liver transplant patients, but there is limited evidence of the same in critically ill cirrhotic patients. In this study, the investigators tried to demonstrate the comparison of blood products used to treat coagulopathy based on TEG versus ROTEM algorithms in cirrhotic patients presenting with non variceal bleeding

Detailed Description
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Thromboelastography (TEG) and thromboelastometry( ROTEM) are point-of-care, global hemostasis assessment tests that measure the viscoelastic changes that occur during the hemostatic process. Patients with cirrhosis have an imbalance of procoagulants and anticoagulants combined with alterations in fibrinolysis ,platelet number and function. Point of care viscoelastic tests (TEG ,ROTEM) demonstrate specific functional coagulation defects that can direct blood component transfusion therapy in cirrhosis, with clinical validation of individual parameters. Studies comparing Thromboelastography or Rotational thromboelastometry versus standard coagulation tests are abundant. Data comparing the two exclusively in a liver intensive care set up is limited. Studies show that TEG and ROTEM cannot be used interchangeably in trauma, liver transplant patients, but there is limited evidence of the same in critically ill cirrhotic patients. In this study, the investigators tried to demonstrate the comparison of blood products used to treat coagulopathy based on TEG versus ROTEM algorithms in cirrhotic patients presenting with non variceal bleeding

Official Title
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A Comparative Evaluation of Thromboelastography Versus Thromboelastometry for Coagulopathy Correction in Patients of Liver Cirrhosis With Non Variceal Bleed- Prospective Observational Study

Conditions
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Liver Cirrhosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients of liver cirrhosis with non variceal bleed Exclusion Criteria: Pregnant and postpartum patients died within the first 24hours of admission. variceal and postvariceal ligation ulcer bleed. On anticoagulants or antiplatelets at the time of admission in ICU Transfusion with blood products before admission to the ICU.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TEG group<br>Thromboelastography guided blood product administration in patients of liver cirrhosis with non variceal bleed | |
| ROTEM group<br>Throboelastometry guided blood product administration in patients of liver cirrhosis with non variceal bleed | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total amount of blood products transfused at 8 hours(FFP, Cryoprecipitate, platelets) will be measured | Total amount of blood products transfused at 8 hours(FFP, Cryoprecipitate, platelets) will be measured | 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R time of thromboelastography | R time measures time to start forming clot | 8 hours | 
| K time of thromboelastography | K time represents time until clot reaches a fixed strength | 8 hours | 
| alpha angle of thromboelastography | alpha angle represents speed of fibrin accumulation | 8 hours | 
| Maximum amplitude of thromboleastography | It represents the highest vertical amplitude of thromboelastography | 8 hours | 
| LY30 Iin thromboelastometry | It represents the percentage of amplitude reduction 30 minutes after reaching maximum amplitude | 8 hours | 
| Clotting time in thromboelastometry | It represents the time to start forming clot and initial fibrin formation | 8 hours | 
| Clot formation time in thromboelastometry | It represents the clot strengthening and rapidity of fibrin build up | 8 hours | 
| Maximum clot firmness in thromboelastometry | It represents the highest vertical amplitude of the thromboelastometry graph and represents clot strength | 8 hours | 
| LI30 in thromboelastometry | It represents clot breakdown and fibrinolysis at fixed time | 8 hours | 
| Control of bleeding at 48 hours | The investigators would measure the hemoglobin levels to see for any drop in concentration of hemoglobin | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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THROMBOELASTOGRAPHY, THROMBOELASTOMETRY, nonvariceal, bleeding