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

Status unconfirmed

Conditions studied: Blood Coagulation Disorders

In brief

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.

Key facts

Study ID

NCT02379104

Run by

Tem Innovations GmbH

People needed

240

Starts

2017-10-01

Expected to finish

2018-12-01

Last updated by the study team

2017-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Medi. Medical University Innsbruck Department of General and Surgical Intensive Care Medicine, Medical University Innsbruck — Innsbruck, Austria (enrolling)
• Institute of Anaesthesiology, Section Anaesthesiology, Intensive Care Medicine and OR-Management University Hospital Zurich — Zurich, Switzerland (enrolling)
• Florida Hospital Center for Thrombosis Research — Orlando, Florida, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Department of Anesthesiology Weill Cornell Medical College New York-Presbyterian Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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