Blood Coagulation DisordersROSI-EVANCT02379104
ROTEM® Sigma Performance Evaluation - Method Comparison With Predicate Device and Reference Intervals
An observational study of Blood Coagulation Disorders, run by Tem Innovations GmbH at 5 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Coagulation Disorders
- What is being tested?
- ROTEM sigma
- Type of treatment
- Medical device
- How many people
- 240 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Oct 2017to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Patients with expected bleeding and coagulation problems during elective surgery or at the ICU, or trauma patients * Healthy volunteers
Who may be able to join
- 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
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- Healthy Volunteers:
- Adult healthy individuals (≥ 18 years)
- Written informed consent
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States3 sites, 3 recruiting
- Not yet recruiting
University of Maryland Medical Center
Baltimore, Maryland, 21201
Ken Tanaka, MD MSc, ktanaka@anes.umm.edu
Ken Tanaka, MD MSc
- Not yet recruiting
Department of Anesthesiology Weill Cornell Medical College New York-Presbyterian Hospital
New York, New York, 10065
Hugh Hemmings, MD PhD, mls9004@med.cornell.edu
Hugh Hemmings, MD PhD
- Not yet recruiting
Florida Hospital Center for Thrombosis Research
Orlando, Florida, 32789
John Francis, MD PhD, john.francis@flhosp.org
John Francis, MD PhD
Austria1 site, 1 recruiting
- Recruiting
Medi. Medical University Innsbruck Department of General and Surgical Intensive Care Medicine, Medical University Innsbruck
Innsbruck, 6020
Dietmar Fries, Prof. Dr., +43 (0)512 504 80455, dietmar.fries@uki.at
Dietmar Fries, Prof. Dr.
Switzerland1 site, 1 recruiting
- Recruiting
Institute of Anaesthesiology, Section Anaesthesiology, Intensive Care Medicine and OR-Management University Hospital Zurich
Zurich, 8091
Oliver Theusinger, PD Dr., +41 (0)44 255 2710, oliver.theusinger@usz.ch
Oliver Theusinger, PD Dr.
About this study
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.
Read the detailed description
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.
- Conditions
- Blood Coagulation Disorders
- Being tested
- ROTEM sigma
- Medical subject headings
- Blood Coagulation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROTEM sigmaDevice
Also called ROTEM delta
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
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Healthy volunteers fulfilling inclusion/exclusion criteria for reference interval sample group are tested with ROTEM sigma Receives: Device: ROTEM sigma | |
| 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 Receives: Device: ROTEM sigma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Method comparison: linear regression analysis and bias estimation at medical decision limits
Measured: Parameter differences assessed at time of blood sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startOct 2017 (estimated)
- Primary completionOct 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Coagulation DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tem Innovations GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Volker Friemert, Dr., Study chair, Tem Innovations GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379104
- Sponsor's protocol ID
- RSE2015
- Acronym
- ROSI-EVA
- Status last verified
- May 2017
- First submitted
- 12 Feb 2015
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROTEM® Sigma Performance Evaluation - Method Comparison With Predicate Device and Reference Intervals
- ClinicalTrials.gov ID
- NCT02379104
- Acronym / sponsor ID
- ROSI-EVA / RSE2015
- Conditions
- Blood Coagulation Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Tem Innovations GmbHIndustry (pharma, biotech, devices)
- Study start
- Oct 2017 (estimated)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 4 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Device: ROTEM sigmaHealthy volunteers fulfilling inclusion/exclusion criteria for reference interval sample group are tested with ROTEM sigma |
| Patients with expected coagulopathy | – | Device: ROTEM sigmaPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients with expected bleeding and coagulation problems during elective surgery or at the ICU, or trauma patients * Healthy volunteers
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- none
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROTEM sigmaAlso: ROTEM deltaGroup 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 | Device | Healthy Volunteers, Patients with expected coagulopathy |
Primary outcome
Method comparison: linear regression analysis and bias estimation at medical decision limits
Time frame: Parameter differences assessed at time of blood sampling
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Volker Friemert, Dr. study chair
Tem Innovations GmbH
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Coagulation Disorders, run by Tem Innovations GmbH at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Austria, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Volker Friemert, Dr. (+49 89 454295 ext. 11, volker-joachim.friemert@tem-innovations.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Method comparison: linear regression analysis and bias estimation at medical decision limits (time frame: Parameter differences assessed at time of blood sampling). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.