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A Comparative Evaluation of TEG Versus ROTEM for Coagulopathy Correction

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05333510
Enrollment
60
Registered
2022-04-19
Start date
2021-07-01
Completion date
2022-01-08
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis

Keywords

THROMBOELASTOGRAPHY, THROMBOELASTOMETRY, nonvariceal, bleeding

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

Interventions

None listed

Sponsors

Institute of Liver and Biliary Sciences, India
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* patients of liver cirrhosis with non variceal bleed

Exclusion criteria

1. Pregnant and postpartum patients 2. died within the first 24hours of admission. 3. variceal and postvariceal ligation ulcer bleed. 4. On anticoagulants or antiplatelets at the time of admission in ICU 5. Transfusion with blood products before admission to the ICU.

Design outcomes

Primary

MeasureTime frameDescription
Total amount of blood products transfused at 8 hours(FFP, Cryoprecipitate, platelets) will be measured8 hoursTotal amount of blood products transfused at 8 hours(FFP, Cryoprecipitate, platelets) will be measured

Secondary

MeasureTime frameDescription
K time of thromboelastography8 hoursK time represents time until clot reaches a fixed strength
alpha angle of thromboelastography8 hoursalpha angle represents speed of fibrin accumulation
Maximum amplitude of thromboleastography8 hoursIt represents the highest vertical amplitude of thromboelastography
LY30 Iin thromboelastometry8 hoursIt represents the percentage of amplitude reduction 30 minutes after reaching maximum amplitude
R time of thromboelastography8 hoursR time measures time to start forming clot
Clot formation time in thromboelastometry8 hoursIt represents the clot strengthening and rapidity of fibrin build up
Maximum clot firmness in thromboelastometry8 hoursIt represents the highest vertical amplitude of the thromboelastometry graph and represents clot strength
LI30 in thromboelastometry8 hoursIt represents clot breakdown and fibrinolysis at fixed time
Control of bleeding at 48 hours48 hoursThe investigators would measure the hemoglobin levels to see for any drop in concentration of hemoglobin
Clotting time in thromboelastometry8 hoursIt represents the time to start forming clot and initial fibrin formation

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026