A Comparative Evaluation of TEG Versus ROTEM for Coagulopathy Correction

NCT05333510 | Completed DMC

• 1 other identifier: IEC/2021/86/MA06
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Liver Cirrhosis

Keywords

THROMBOELASTOGRAPHY; THROMBOELASTOMETRY; nonvariceal; bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• R time of thromboelastography

  8 hours

• K time of thromboelastography

  8 hours

• alpha angle of thromboelastography

  8 hours

• Maximum amplitude of thromboleastography

  8 hours

• LY30 Iin thromboelastometry

  8 hours

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• patients of liver cirrhosis with non variceal bleed

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

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

Location

Related Publications (4)

• 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.

  PMID: 30589495 BACKGROUND

• 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.

  PMID: 31148204 BACKGROUND

• 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.

  PMID: 27552162 BACKGROUND

• 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.

  PMID: 32489202 BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis; Hemorrhage

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• NIMI GOPAL

  Institute of Liver and Biliary Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: April 19, 2022
• Study Start: July 1, 2021
• Primary Completion: January 8, 2022
• Study Completion: January 8, 2022
• Last Updated: April 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)