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Clinical Trials/NCT05333510
NCT05333510
Completed
Not Applicable

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

Institute of Liver and Biliary Sciences, India1 site in 1 country60 target enrollmentJuly 1, 2021
ConditionsLiver Cirrhosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Liver Cirrhosis
Sponsor
Institute of Liver and Biliary Sciences, India
Enrollment
60
Locations
1
Primary Endpoint
Total amount of blood products transfused at 8 hours(FFP, Cryoprecipitate, platelets) will be measured
Status
Completed
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
July 1, 2021
End Date
January 8, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Time Frame: 8 hours

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

Secondary Outcomes

  • LY30 Iin thromboelastometry(8 hours)
  • LI30 in thromboelastometry(8 hours)
  • Control of bleeding at 48 hours(48 hours)
  • Maximum amplitude of thromboleastography(8 hours)
  • K time of thromboelastography(8 hours)
  • alpha angle of thromboelastography(8 hours)
  • Clot formation time in thromboelastometry(8 hours)
  • Maximum clot firmness in thromboelastometry(8 hours)
  • R time of thromboelastography(8 hours)
  • Clotting time in thromboelastometry(8 hours)

Study Sites (1)

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