Non Inferiority of the Quantra DeviceNCT04210830
Comparison Two Point of Care Coagulation Monitoring Systems - the ROTEM Sigma and the Quantra Devic
An observational study of Non Inferiority of the Quantra Device, run by Klinik Hirslanden, Zurich at 1 site in Switzerland.
Trial summary
Human Research Project Risk Category A. In this study no additional intervention or treatment are performed. The whole blood samples are taken from a routinely placed arterial catheter. The blood loss caused by the two additional blood samples is estimated with 2x 2.7ml. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Inferiority of the Quantra Device
- What is being tested?
- Quantra-Device
- How many people
- 35 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2018to 3 Oct 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: cardiac surgery patients
Who may be able to join
- Patients scheduled for cardiac surgery needing a cardiopulmonary bypass
- Age older than18 years
- Written consent of the participation after clarification about the study
Who cannot join
- No consent to participate
- No German comprehension
- Known coagulation disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Methods for Coagulation Analysis Between Rotem Sigma (Instrumentation Laboratory, Bedfort, MA, USA) and Quantra System (Hemosonics, Charlottesville, VA USA) in Cardiac Surgery
Human Research Project Risk Category A. In this study no additional intervention or treatment are performed. The whole blood samples are taken from a routinely placed arterial catheter. The blood loss caused by the two additional blood samples is estimated with 2x 2.7ml. The Risk for the patients to participate in this study is minimal.
Clinical observational study of a point of care in vitro diagnostic device, the Quantra®system (Quantra), that received the CE Mark in April 2017 and is approved by the Swiss Medic for clinical use. The Quantra estimates the coagulation strength of whole blood by sonorheometry technology applying a series of ultrasound pulses to a whole blood sample and measuring its stiffness by returning echoes.
Read the detailed description
The purpose of this study is to investigate to what extent the results of the Quantra corresponds to those of the ROTEM® Sigma (ROTEM). Additionally, the time required for delivery of final results (turnaround time) of all parameters of the Quantra will be examined. Significant differences in the turnaround time between both devices are of high interest as timing is a crucial factor in the diagnosis-based treatment.
Comparison of the coagulation process measurements in turnaround time and results of the ROTEM INTEM CT, HEPTEM CT, EXTEM A10 FIBTEM A10 with corresponding Quantra parameters such as CT, CTH, CTR, CS, PCS, FCS.
The primary aim of the study is to examine whether the two methods of hemostasis analysis are equivalent and how far they correlate.
Secondary aims are to examine the turnaround time of test results in both devices and to examine whether these results would have led to the same therapeutic decisions in a retrospective review of data.
For both devices following data is documented:
- Time for cartridge insertion
- Time first results available
- Time measurement finished
Parameters measured ROTEM Quantra
- INTEM CT Clot Time (CT)
- HEPTEM CT Heparinase Clot time
- (CTH)
- INTEM CT/HEPTEM CT Clot Time Ratio (CTR)
- EXTEM A10 Clot Stiffness (CS)
- FIBTEM A10 Fibrinogen Contribution
- to Clot Stiffness (FCS)
- EXTEM A10 - FIBTEM A10 Platelet Contribution to
- Clot Stiffness (PCS)
Blood loss estimated (mL/6h; mL/12h; mL/24 h) RCP transfused FFP packages transfused Platelet packages transfused Fibrinogen applied F XIII applied
Quantra clot stiffness values are expressed in hectoPascals (hPa), whereas corresponding ROTEM values are expressed as an amplitude in mm. The relationship between amplitude (A in mm) and shear modulus (G in Pascals) is not linear. For a proper comparison the ROTEM amplitude (mm) needs to be converted to Pascals by following formula:
G (Pascals) = (500 x A) / (100 - A),
as described by Solomon C et al, Anaesth Analg 2015; 121:868-78.
The Quantra data that are collected during the study are only observational and will not be used to guide therapeutic interventions
- Conditions
- Non Inferiority of the Quantra Device
- Being tested
- Quantra-Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantra-DeviceDiagnostic test
Point of Care Coagulation Monitoring System
What is being measured
The primary outcome is the main question the study is designed to answer.
Equivalence of the results of both devices
Comparision of the results of the INTEM CT (R) with the Clot Time (Q)
Measured: 1 Year
Equivalence of the results of both devices
HEPTEM CT (R) was compared with the Heparinase Clot ime (Q)
Measured: 1 Year
Equivalence of results of both devices
INTEM CT/HEPTEM CT (R) was compared with the Clot Time Ratio (Q)
Measured: 1 Year
Equivalence of results of both devices
EXTEM A10 (R) was compared with the Clot Stiffness (Q)
Measured: 1 Year
Equivalence of results of both devices
FIBTEM A10 (R) was compared with the Fibrinogen Contribution to Clot Stiffness (Q)
Measured: 1 Year
Equivalence of results of both devices
Difference of EXTEM A10 and FIBTEM A10 (R) was compared with the Platelet Contribution to Clot Stiffness (Q)
Measured: 1 Year
Secondary outcomes (3)
Turnaround time of the measurements
Time from taking the blood sample until introduction the Cartridge, in seconds
Measured: 1 Year
Turnaround time of the measurements
Time from Insertion the Cartridge until the first plotted result
Measured: 1 Year
Turnaround time of the measurements
Time from insertion the Cartridge until the all results are plotted
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start1 Nov 2018
- Primary completion3 Oct 2019
- Study completion3 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Inferiority of the Quantra DeviceStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinik Hirslanden, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Werner Baulig, Klinik Hirslanden, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210830
- Sponsor's protocol ID
- KlinikHirslande
- Status last verified
- Dec 2019
- First submitted
- 3 Oct 2019
- Last updated
- 26 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Baulig W, Akbas S, Schutt PK, Keul W, Jovic M, Berdat P, von Felten S, Steigmiller K, Ganter MT, Theusinger OM. Comparison of the resonance sonorheometry based Quantra(R) system with rotational thromboelastometry ROTEM(R) sigma in cardiac surgery - a prospective observational study. BMC Anesthesiol. 2021 Oct 28;21(1):260. doi: 10.1186/s12871-021-01469-5.
PubMed 34711167
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Methods for Coagulation Analysis Between Rotem Sigma (Instrumentation Laboratory, Bedfort, MA, USA) and Quantra System (Hemosonics, Charlottesville, VA USA) in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04210830
- Acronym / sponsor ID
- KlinikHirslande
- Conditions
- Non Inferiority of the Quantra Device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Klinik Hirslanden, ZurichUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 3 Oct 2019 (actual)
- Study completion
- 3 Oct 2019 (actual)
- First posted
- 26 Dec 2019 (actual)
- 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.
Human Research Project Risk Category A. In this study no additional intervention or treatment are performed. The whole blood samples are taken from a routinely placed arterial catheter. The blood loss caused by the two additional blood samples is estimated with 2x 2.7ml. The Risk for the patients to participate in this study is minimal.
Clinical observational study of a point of care in vitro diagnostic device, the Quantra®system (Quantra), that received the CE Mark in April 2017 and is approved by the Swiss Medic for clinical use. The Quantra estimates the coagulation strength of whole blood by sonorheometry technology applying a series of ultrasound pulses to a whole blood sample and measuring its stiffness by returning echoes.
Detailed description
The purpose of this study is to investigate to what extent the results of the Quantra corresponds to those of the ROTEM® Sigma (ROTEM). Additionally, the time required for delivery of final results (turnaround time) of all parameters of the Quantra will be examined. Significant differences in the turnaround time between both devices are of high interest as timing is a crucial factor in the diagnosis-based treatment.
Comparison of the coagulation process measurements in turnaround time and results of the ROTEM INTEM CT, HEPTEM CT, EXTEM A10 FIBTEM A10 with corresponding Quantra parameters such as CT, CTH, CTR, CS, PCS, FCS.
The primary aim of the study is to examine whether the two methods of hemostasis analysis are equivalent and how far they correlate.
Secondary aims are to examine the turnaround time of test results in both devices and to examine whether these results would have led to the same therapeutic decisions in a retrospective review of data.
For both devices following data is documented:
- Time for cartridge insertion
- Time first results available
- Time measurement finished
Parameters measured ROTEM Quantra
- INTEM CT Clot Time (CT)
- HEPTEM CT Heparinase Clot time
- (CTH)
- INTEM CT/HEPTEM CT Clot Time Ratio (CTR)
- EXTEM A10 Clot Stiffness (CS)
- FIBTEM A10 Fibrinogen Contribution
- to Clot Stiffness (FCS)
- EXTEM A10 - FIBTEM A10 Platelet Contribution to
- Clot Stiffness (PCS)
Blood loss estimated (mL/6h; mL/12h; mL/24 h) RCP transfused FFP packages transfused Platelet packages transfused Fibrinogen applied F XIII applied
Quantra clot stiffness values are expressed in hectoPascals (hPa), whereas corresponding ROTEM values are expressed as an amplitude in mm. The relationship between amplitude (A in mm) and shear modulus (G in Pascals) is not linear. For a proper comparison the ROTEM amplitude (mm) needs to be converted to Pascals by following formula:
G (Pascals) = (500 x A) / (100 - A),
as described by Solomon C et al, Anaesth Analg 2015; 121:868-78.
The Quantra data that are collected during the study are only observational and will not be used to guide therapeutic interventions
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cardiac surgery patients
Key inclusion criteria (3 listed)
- Patients scheduled for cardiac surgery needing a cardiopulmonary bypass
- Age older than18 years
- Written consent of the participation after clarification about the study
Key exclusion criteria (3 listed)
- No consent to participate
- No German comprehension
- Known coagulation disorder
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 |
|---|---|---|
| Quantra-DevicePoint of Care Coagulation Monitoring System | Diagnostic test | – |
Primary outcome
Equivalence of the results of both devices
Time frame: 1 Year
Comparision of the results of the INTEM CT (R) with the Clot Time (Q)
Equivalence of the results of both devices
Time frame: 1 Year
HEPTEM CT (R) was compared with the Heparinase Clot ime (Q)
Equivalence of results of both devices
Time frame: 1 Year
INTEM CT/HEPTEM CT (R) was compared with the Clot Time Ratio (Q)
Equivalence of results of both devices
Time frame: 1 Year
EXTEM A10 (R) was compared with the Clot Stiffness (Q)
Equivalence of results of both devices
Time frame: 1 Year
FIBTEM A10 (R) was compared with the Fibrinogen Contribution to Clot Stiffness (Q)
Equivalence of results of both devices
Time frame: 1 Year
Difference of EXTEM A10 and FIBTEM A10 (R) was compared with the Platelet Contribution to Clot Stiffness (Q)
3 secondary outcomes
Turnaround time of the measurements
Time frame: 1 Year
Turnaround time of the measurements
Time frame: 1 Year
Turnaround time of the measurements
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
- Derived from this study: PubMed 34711167Baulig W, Akbas S, Schutt PK, Keul W, Jovic M, Berdat P, von Felten S, Steigmiller K, Ganter MT, Theusinger OM. Comparison of the resonance sonorheometry based Quantra(R) system with rotational thromboelastometry ROTEM(R) sigma in cardiac surgery - a prospective observational study. BMC Anesthesiol. 2021 Oct 28;21(1):260. doi: 10.1186/s12871-021-01469-5.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Inferiority of the Quantra Device, run by Klinik Hirslanden, Zurich at 1 site in Switzerland.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Equivalence of the results of both devices (time frame: 1 Year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04210830, which also lists 1 linked publication.
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 26 Dec 2019.