ROTEM® Sigma Performance Evaluation - Method Comparison With Predicate Device and Reference Intervals
NCT ID: NCT02379104
Last Updated: 2017-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
240 participants
OBSERVATIONAL
2017-10-31
2018-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Method comparison of ROTEM® sigma with predecessor model ROTEM® delta) - confirmation of equality.
Confirmation of reference intervals of the ROTEM® systems.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Viscoelastic Measurement by ROTEM® Delta and ClotPro® in Trauma Patients.
NCT04107818
Comparative Analysis of PCM With ROTEM in the Measurement of Viscoelastic Coagulation Parameters
NCT03679286
Comparison Two Point of Care Coagulation Monitoring Systems - the ROTEM Sigma and the Quantra Devic
NCT04210830
Equivalency Study of the TEG and CORA Hemostasis Systems
NCT01790386
Use of Rotational Thromboelastometry (ROTEM) to Characterize Coagulation Abnormalities in Burn Patients
NCT02388776
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Healthy Volunteers
Healthy volunteers fulfilling inclusion/exclusion criteria for reference interval sample group are tested with ROTEM sigma
ROTEM sigma
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
Patients with expected coagulopathy
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
ROTEM sigma
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ROTEM sigma
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
• 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tem Innovations GmbH
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Volker Friemert, Dr.
Role: STUDY_CHAIR
Tem Innovations GmbH
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Medi. Medical University Innsbruck Department of General and Surgical Intensive Care Medicine, Medical University Innsbruck
Innsbruck, , Austria
Institute of Anaesthesiology, Section Anaesthesiology, Intensive Care Medicine and OR-Management University Hospital Zurich
Zurich, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RSE2015
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.