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

• Conditions: Blood Coagulation Disorders
• Interventions: Device: ROTEM sigma

• Registration Number: NCT02379104
• Lead Sponsor: Tem Innovations GmbH

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-02-12
• Study First Submitted QC: 2015-02-26
• Study First Posted: 2015-03-04
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-10
• Last Update Posted: 2017-05-11
• Study Start: 2017-10
• Primary Completion: 2018-10
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with expected coagulopathy	ROTEM sigma	Patients with expected bleeding and coagulation problems during elective surgery or at the ICU, or trauma patients are tested with ROTEM sigma and ROTEM delta comparatively
Healthy Volunteers	ROTEM sigma	Healthy volunteers fulfilling inclusion/exclusion criteria for reference interval sample group are tested with ROTEM sigma

Primary Outcome Measures

Name	Time	Method
Method comparison: linear regression analysis and bias estimation at medical decision limits	Parameter differences assessed at time of blood sampling

Trial Locations

Locations (5)

Institute of Anaesthesiology, Section Anaesthesiology, Intensive Care Medicine and OR-Management University Hospital Zurich; 🇨🇭 Zurich, Switzerland

Florida Hospital Center for Thrombosis Research; 🇺🇸 Orlando, Florida, United States

Medi. Medical University Innsbruck Department of General and Surgical Intensive Care Medicine, Medical University Innsbruck; 🇦🇹 Innsbruck, Austria

Department of Anesthesiology Weill Cornell Medical College New York-Presbyterian Hospital; 🇺🇸 New York, New York, United States

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States