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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Blood Coagulation Disorders

Intervention / Treatment
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* Device: ROTEM sigma


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Volunteers<br>Healthy volunteers fulfilling inclusion/exclusion criteria for reference interval sample group are tested with ROTEM sigma | Device: ROTEM sigma<br>* 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<br>* Other names: ROTEM delta;|
| Patients with expected coagulopathy<br>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 | Device: ROTEM sigma<br>* 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<br>* Other names: ROTEM delta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Method comparison: linear regression analysis and bias estimation at medical decision limits |  | Parameter differences assessed at time of blood sampling |