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

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

Study Overview

• Status: Completed
• Conditions: Liver Cirrhosis

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

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of Liver and Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients of liver cirrhosis who are presenting with non variceal bleed would be included in this study

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
TEG group; Thromboelastography guided blood product administration in patients of liver cirrhosis with non variceal bleed
ROTEM group; Throboelastometry guided blood product administration in patients of liver cirrhosis with non variceal bleed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India
• Investigators: Principal Investigator: NIMI GOPAL, Institute of Liver and Biliary Sciences

Publications and helpful links

General Publications

• 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.
• 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.
• Wikkelso A, Wetterslev J, Moller 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;2016(8):CD007871. doi: 10.1002/14651858.CD007871.pub3.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2021
• Primary Completion (ACTUAL): January 8, 2022
• Study Completion (ACTUAL): January 8, 2022

Study Registration Dates

• First Submitted: January 13, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (ACTUAL): April 19, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 19, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: bleeding; THROMBOELASTOGRAPHY; THROMBOELASTOMETRY; nonvariceal
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: IEC/2021/86/MA06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No