A Comparative Evaluation of TEG Versus ROTEM for Coagulopathy Correction
- Conditions
- Liver Cirrhosis
- Registration Number
- NCT05333510
- Lead Sponsor
- Institute of Liver and Biliary Sciences, India
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- patients of liver cirrhosis with non variceal bleed
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total amount of blood products transfused at 8 hours(FFP, Cryoprecipitate, platelets) will be measured 8 hours Total amount of blood products transfused at 8 hours(FFP, Cryoprecipitate, platelets) will be measured
- Secondary Outcome Measures
Name Time Method LY30 Iin thromboelastometry 8 hours It represents the percentage of amplitude reduction 30 minutes after reaching maximum amplitude
LI30 in thromboelastometry 8 hours It represents clot breakdown and fibrinolysis at fixed time
Control of bleeding at 48 hours 48 hours The investigators would measure the hemoglobin levels to see for any drop in concentration of hemoglobin
Maximum amplitude of thromboleastography 8 hours It represents the highest vertical amplitude of thromboelastography
K time of thromboelastography 8 hours K time represents time until clot reaches a fixed strength
alpha angle of thromboelastography 8 hours alpha angle represents speed of fibrin accumulation
Clot formation time in thromboelastometry 8 hours It represents the clot strengthening and rapidity of fibrin build up
Maximum clot firmness in thromboelastometry 8 hours It represents the highest vertical amplitude of the thromboelastometry graph and represents clot strength
R time of thromboelastography 8 hours R time measures time to start forming clot
Clotting time in thromboelastometry 8 hours It represents the time to start forming clot and initial fibrin formation
Trial Locations
- Locations (1)
Institute of Liver and Biliary Sciences
🇮🇳New Delhi, Delhi, India