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Completed

NCT Number: NCT05333510

A Comparative Evaluation of TEG Versus ROTEM for Coagulopathy Correction

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. R time of thromboelastography

    Time frame: 8 hours

    R time measures time to start forming clot

  2. K time of thromboelastography

    Time frame: 8 hours

    K time represents time until clot reaches a fixed strength

  3. alpha angle of thromboelastography

    Time frame: 8 hours

    alpha angle represents speed of fibrin accumulation

  4. Maximum amplitude of thromboleastography

    Time frame: 8 hours

    It represents the highest vertical amplitude of thromboelastography

  5. LY30 Iin thromboelastometry

    Time frame: 8 hours

    It represents the percentage of amplitude reduction 30 minutes after reaching maximum amplitude

  6. Clotting time in thromboelastometry

    Time frame: 8 hours

    It represents the time to start forming clot and initial fibrin formation

  7. Clot formation time in thromboelastometry

    Time frame: 8 hours

    It represents the clot strengthening and rapidity of fibrin build up

  8. Maximum clot firmness in thromboelastometry

    Time frame: 8 hours

    It represents the highest vertical amplitude of the thromboelastometry graph and represents clot strength

  9. LI30 in thromboelastometry

    Time frame: 8 hours

    It represents clot breakdown and fibrinolysis at fixed time

  10. Control of bleeding at 48 hours

    Time frame: 48 hours

    The investigators would measure the hemoglobin levels to see for any drop in concentration of hemoglobin

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 19, 2022
Registry last updated
Apr 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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