Blood Coagulation Disorders Clinical Trial
Official title:
ROTEM® Sigma Performance Evaluation - Method Comparison With Predicate Device and Reference Intervals
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.
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.
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