ROTEM® Sigma Performance Evaluation - Method Comparison With Predicate Device and Reference Intervals
| Status: | Recruiting |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/12/2017 |
| Start Date: | October 2017 |
| End Date: | December 2018 |
| Contact: | Volker Friemert, Dr. |
| Email: | volker-joachim.friemert@tem-innovations.de |
| Phone: | +49 89 454295 |
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.
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.
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.
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.
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
We found this trial at
4
sites
Orlando, Florida 32789
Principal Investigator: John Francis, MD PhD
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22 S Greene St
Baltimore, Maryland 21201
Baltimore, Maryland 21201
(410) 328-8667
Principal Investigator: Ken Tanaka, MD MSc
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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Innsbruck,
Principal Investigator: Dietmar Fries, Prof. Dr.
Phone: +43 (0)512 504 80455
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New York, New York 10065
Principal Investigator: Hugh Hemmings, MD PhD
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