ROTEM® Sigma Performance Evaluation - Method Comparison With Predicate Device and Reference Intervals

Blood Coagulation Disorders Clinical Trial

— ROSI-EVA  

Official title:

ROTEM® Sigma Performance Evaluation - Method Comparison With Predicate Device and Reference Intervals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02379104
• Other study ID #: RSE2015
• Status: Recruiting
• Phase: N/A
• First received: February 12, 2015
• Last updated: May 10, 2017
• Start date: October 2017
• Est. completion date: December 2018

Study information

• Verified date: May 2017
• Source: Tem Innovations GmbH
• Contact: Volker Friemert, Dr.
• Phone: +49 89 454295
• Email: volker-joachim.friemert[@]tem-innovations.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

ROTEM® sigma is a new thromboelastometric coagulation analysis system. The new system is fully automated allowing for a simple and safe operation compared to its predecessor model ROTEM® delta.

Method comparison of ROTEM® sigma with predecessor model ROTEM® delta) - confirmation of equality.

Confirmation of reference intervals of the ROTEM® systems.

Description:

The main innovation of ROTEM® sigma is the development of a sample handler and a cartridge allowing for a of full automated test operation. As in ROTEM® delta four different tests can be run simultaneously on the four channels of the analyser.

Whereas the tests in ROTEM® delta are performed manually by pipetting a blood sample and liquid system reagents, in ROTEM® sigma the reagents are contained in freeze dried pellet form in a cartridge. Test operation is performed by inserting a cartridge and attaching a blood sample to the analyser.

The five available ROTEM® tests INTEM, EXTEM, FIBTEM, APTEM, and HEPTEM are contained in different combinations in two cartridge configurations:

• Cartridge type 1 including INTEM, EXTEM, FIBTEM, APTEM

• Cartridge type 2 including INTEM, EXTEM, FIBTEM, HEPTEM

Aim of the study is the performance evaluation of the new ROTEM® sigma coagulation analyzer in comparison to the current ROTEM® delta thromboelastometry system.

As a valid method comparison requires test results that cover the whole measurement range of the test system it is also necessary to include acute bleeding and emergency patients in the study. Only the inclusion of acute bleeding and emergency patients will produce strong pathologic test results allowing for a valid evaluation of the test system.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients:

• Age = 18 years

• Informed written consent

• Patients with an acute bleeding during surgery

• Or: trauma patients with acute bleeding

• Or: hypercoagulable (above normal fibrinogen) patients at the ICU

Healthy Volunteers:

• Adult healthy individuals (= 18 years)

• Written informed consent

Exclusion Criteria:

Patients:

• none

Healthy Volunteers:

• Any indications of alcohol or illegal drug abuse

• Any chronic disease with possible effect on the coagulation (liver disease, coronary heart disease)

• Any acute illness within the last 14 days

• Any hemostasis associated disease (myocardial infarction, thrombosis , stroke etc.) within the last year

• Intake of any coagulation affecting medication (aspirin, pain-killers, anti-rheumatic drugs, marcumar, platelet inhibitors) within the last 14 days

• Females only: known pregnancy

• Females only: breast feeding

• Any indication for any hemostasis disorder as interrogated by a specific history of bleeding tendencies

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Hemostatic Disorders

Intervention

Device:
• ROTEM sigma
Group Healthy Volunteers: a blood sample is tested with ROTEM sigma Group Patients with expected coagulopathy: a blood sample is tested with ROTEM sigma and ROTEM delta in parallel

Locations

Country	Name	City	State
Austria	Medi. Medical University Innsbruck Department of General and Surgical Intensive Care Medicine, Medical University Innsbruck	Innsbruck
Switzerland	Institute of Anaesthesiology, Section Anaesthesiology, Intensive Care Medicine and OR-Management University Hospital Zurich	Zurich
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Department of Anesthesiology Weill Cornell Medical College New York-Presbyterian Hospital	New York	New York
United States	Florida Hospital Center for Thrombosis Research	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Tem Innovations GmbH

Countries where clinical trial is conducted

United States,  Austria,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Method comparison: linear regression analysis and bias estimation at medical decision limits		Parameter differences assessed at time of blood sampling