Clinical trial NCT02379104: ROTEM® Sigma Performance Evaluation - Method Comparison With Predicate Device and Reference Intervals
Official title: ROTEM® Sigma Performance Evaluation - Method Comparison With Predicate Device and Reference Intervals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Coagulation Disorders
Lead sponsor: Tem Innovations GmbH
Sponsor class: INDUSTRY
First posted: 2015-03-04
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Patients with expected bleeding and coagulation problems during elective surgery or at the ICU, or trauma patients
* Healthy volunteers

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.

Eligibility criteria: 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

Primary outcomes:
measure: Method comparison: linear regression analysis and bias estimation at medical decision limits
timeFrame: Parameter differences assessed at time of blood sampling
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Florida Hospital Center for Thrombosis Research
state: Florida
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: New York
country: United States
facility: Department of Anesthesiology Weill Cornell Medical College New York-Presbyterian Hospital
state: New York
city: Innsbruck
country: Austria
facility: Medi. Medical University Innsbruck Department of General and Surgical Intensive Care Medicine, Medical University Innsbruck
city: Zurich
country: Switzerland
facility: Institute of Anaesthesiology, Section Anaesthesiology, Intensive Care Medicine and OR-Management University Hospital Zurich
Study officials:
affiliation: Tem Innovations GmbH
name: Volker Friemert, Dr.
role: STUDY_CHAIR
References: