Clinical trial NCT05333510: A Comparative Evaluation of TEG Versus ROTEM for Coagulopathy Correction
Official title: A Comparative Evaluation of Thromboelastography Versus Thromboelastometry for Coagulopathy Correction in Patients of Liver Cirrhosis With Non Variceal Bleed- Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cirrhosis
Keywords: THROMBOELASTOGRAPHY
THROMBOELASTOMETRY
nonvariceal
bleeding
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients of liver cirrhosis who are presenting with non variceal bleed would be included in this study

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

Eligibility criteria: 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.

Primary outcomes:
measure: Total amount of blood products transfused at 8 hours(FFP, Cryoprecipitate, platelets) will be measured
timeFrame: 8 hours
Secondary outcomes:
measure: R time of thromboelastography
timeFrame: 8 hours
measure: K time of thromboelastography
timeFrame: 8 hours
measure: alpha angle of thromboelastography
timeFrame: 8 hours
measure: Maximum amplitude of thromboleastography
timeFrame: 8 hours
measure: LY30 Iin thromboelastometry
timeFrame: 8 hours
measure: Clotting time in thromboelastometry
timeFrame: 8 hours
measure: Clot formation time in thromboelastometry
timeFrame: 8 hours
measure: Maximum clot firmness in thromboelastometry
timeFrame: 8 hours
measure: LI30 in thromboelastometry
timeFrame: 8 hours
measure: Control of bleeding at 48 hours
timeFrame: 48 hours
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: NIMI GOPAL
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.
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.