A Comparative Evaluation of TEG Versus ROTEM for Coagulopathy Correction
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Outcome Measures
Primary Outcome Measures
- Total amount of blood products transfused at 8 hours(FFP, Cryoprecipitate, platelets) will be measured [8 hours]
Total amount of blood products transfused at 8 hours(FFP, Cryoprecipitate, platelets) will be measured
Secondary Outcome Measures
- R time of thromboelastography [8 hours]
R time measures time to start forming clot
- K time of thromboelastography [8 hours]
K time represents time until clot reaches a fixed strength
- alpha angle of thromboelastography [8 hours]
alpha angle represents speed of fibrin accumulation
- Maximum amplitude of thromboleastography [8 hours]
It represents the highest vertical amplitude of thromboelastography
- LY30 Iin thromboelastometry [8 hours]
It represents the percentage of amplitude reduction 30 minutes after reaching maximum amplitude
- Clotting time in thromboelastometry [8 hours]
It represents the time to start forming clot and initial fibrin formation
- Clot formation time in thromboelastometry [8 hours]
It represents the clot strengthening and rapidity of fibrin build up
- Maximum clot firmness in thromboelastometry [8 hours]
It represents the highest vertical amplitude of the thromboelastometry graph and represents clot strength
- LI30 in thromboelastometry [8 hours]
It represents clot breakdown and fibrinolysis at fixed time
- Control of bleeding at 48 hours [48 hours]
The investigators would measure the hemoglobin levels to see for any drop in concentration of hemoglobin
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institute of Liver and Biliary Sciences | New Delhi | Delhi | India | 110070 |
Sponsors and Collaborators
- Institute of Liver and Biliary Sciences, India
Investigators
- Principal Investigator: NIMI GOPAL, Institute of Liver and Biliary Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- IEC/2021/86/MA06