A Comparative Evaluation of TEG Versus ROTEM for Coagulopathy Correction

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05333510
• Other study ID #: IEC/2021/86/MA06
• Status: Completed
• Start date: July 1, 2021
• Est. completion date: January 8, 2022

Study information

• Verified date: January 2022
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 8, 2022
• Est. primary completion date: January 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

References & Publications (4)

Kumar M, Ahmad J, Maiwall R, Choudhury A, Bajpai M, Mitra LG, Saluja V, Mohan Agarwal P, Bihari C, Shasthry SM, Jindal A, Bhardwaj A, Kumar G, Sarin SK. Thromboelastography-Guided Blood Component Use in Patients With Cirrhosis With Nonvariceal Bleeding: A Randomized Controlled Trial. Hepatology. 2020 Jan;71(1):235-246. doi: 10.1002/hep.30794. Epub 2019 Aug 27. — View Citation

Premkumar M, Saxena P, Rangegowda D, Baweja S, Mirza R, Jain P, Bhatia P, Kumar G, Bihari C, Kalal C, Vyas T, Choudhury A, Sarin SK. Coagulation failure is associated with bleeding events and clinical outcome during systemic inflammatory response and sepsis in acute-on-chronic liver failure: An observational cohort study. Liver Int. 2019 Apr;39(4):694-704. doi: 10.1111/liv.14034. Epub 2019 Feb 7. — View Citation

Singh SA, Krishnan G, Ashraf H, Subramanian R, Pandey V, Nasa VK, Goyal S, Gupta S. Correlation between thromboelastography and rotational thromboelastometry values in adult liver transplant recipients. Indian J Anaesth. 2020 Apr;64(4):286-291. doi: 10.4103/ija.IJA_762_19. Epub 2020 Mar 28. — View Citation

Wikkelsø A, Wetterslev J, Møller AM, Afshari A. Thromboelastography (TEG) or thromboelastometry (ROTEM) to monitor haemostatic treatment versus usual care in adults or children with bleeding. Cochrane Database Syst Rev. 2016 Aug 22;(8):CD007871. doi: 10.1002/14651858.CD007871.pub3. Review. — View Citation

Outcome

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