Coagulation DisorderNCT03685097
Comparison of Two Point-of-care Devices for Viscoelastic Hemostasis Assays
An observational study of Coagulation Disorder, run by HemoSonics LLC at 1 site in Italy.
Trial summary
This study will investigate the correlation and agreement of Quantra-derived parameters with parameters reported by the ROTEM delta and standard laboratory tests in cardiac surgery patients. In addition the association of Quantra-derived parameters with select platelet function tests will be investigated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coagulation Disorder
- What is being tested?
- Quantra System with the QPlus Cartridge
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2018to 31 Aug 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes subjects 18 years or older undergoing cardiac surgery with cardiopulmonary bypass.
Who may be able to join
- Subject is >18 years
- Subject is undergoing elective cardiac surgery with cardiopulmonary bypass
- Subject is willing to participate and has signed a consent form
Who cannot join
- Subject is younger than 18 years
- Subject has known congenital coagulopathy
- Subject is unable to provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
This study will investigate the correlation and agreement of Quantra-derived parameters with parameters reported by the ROTEM delta and standard laboratory tests in cardiac surgery patients. In addition the association of Quantra-derived parameters with select platelet function tests will be investigated.
Read the detailed description
The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The Quantra QPlus Cartridge (previously called the Surgical Cartridge), was developed to monitor hemostasis during major surgical procedures in adult patients. The cartridge provides six parameters that depict the functional status of a patient's coagulation system.
This single site, prospective observational study will investigate the correlation and agreement of Quantra-derived parameters with parameters reported by the ROTEM delta and standard laboratory tests (PT, aPTT, fibrinogen, platelet count) in cardiac surgery patients. As an additional exploratory study, the association of Quantra-derived parameters with select platelet function tests will be investigated.
- Conditions
- Coagulation Disorder
- Being tested
- Quantra System with the QPlus Cartridge
- Medical subject headings
- Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantra System with the QPlus CartridgeDiagnostic test
Point-of-care viscoelastic testing
| Study group | Role | What they receive |
|---|---|---|
| Cardiac surgery patients | Patients undergoing elective cardiac surgery requiring cardiopulmonary bypass. Receives: Diagnostic Test: Quantra System with the QPlus Cartridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of QPlus Clot Time and Clot Stiffness results to comparable ROTEM delta results
Coagulation function assessed by Quantra QPlus Cartridge and ROTEM delta
Measured: Baseline (before surgery)
Comparison of QPlus Clot Time and Clot Stiffness results to comparable ROTEM delta
Coagulation function assessed by Quantra QPlus Cartridge and ROTEM delta
Measured: After cardiac bypass (10 minutes after administration of protamine)
Comparison of QPlus Clot Time and Clot Stiffness results to standard coagulation test results
Coagulation function assessed by Quantra QPlus Cartridge and standard coagulation tests
Measured: Baseline (before surgery)
Comparison of QPlus Clot Time and Clot Stiffness results to standard coagulation test results
Coagulation function assessed by Quantra QPlus Cartridge and standard coagulation tests
Measured: After cardiac bypass (10 minutes after administration of protamine)
Secondary outcomes (2)
Comparison of QPlus Clot Stiffness results to platelet function tests with multiple electrode aggregometry (MEA): ADPtest and TRAPtest
Platelet function assessed by Quantra QPlus Cartridge and MEA
Measured: Baseline (before surgery)
Comparison of QPlus Clot Stiffness results to platelet function tests with multiple electrode aggregometry (MEA): ADPtest and TRAPtest
Platelet function assessed by Quantra QPlus Cartridge and MEA
Measured: After cardiac bypass (10 minutes after administration of protamine)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start1 Mar 2018
- Primary completion31 Jul 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coagulation DisorderStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- HemoSonics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IRCCS Policlinico S. Donato
- Responsible party
- Sponsor
- Investigators
- Marco Ranucci, MD, Principal investigator, IRCCS Policlinico San Donato (Milan) Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685097
- Sponsor's protocol ID
- HEMCS-013
- Status last verified
- Sep 2018
- First submitted
- 21 Sep 2018
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Point-of-care Devices for Viscoelastic Hemostasis Assays
- ClinicalTrials.gov ID
- NCT03685097
- Acronym / sponsor ID
- HEMCS-013
- Conditions
- Coagulation Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- HemoSonics LLCIndustry (pharma, biotech, devices)
- Collaborators
- IRCCS Policlinico S. Donato
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 26 Sep 2018 (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.
This study will investigate the correlation and agreement of Quantra-derived parameters with parameters reported by the ROTEM delta and standard laboratory tests in cardiac surgery patients. In addition the association of Quantra-derived parameters with select platelet function tests will be investigated.
Detailed description
The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The Quantra QPlus Cartridge (previously called the Surgical Cartridge), was developed to monitor hemostasis during major surgical procedures in adult patients. The cartridge provides six parameters that depict the functional status of a patient's coagulation system.
This single site, prospective observational study will investigate the correlation and agreement of Quantra-derived parameters with parameters reported by the ROTEM delta and standard laboratory tests (PT, aPTT, fibrinogen, platelet count) in cardiac surgery patients. As an additional exploratory study, the association of Quantra-derived parameters with select platelet function tests will be investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac surgery patients | – | Diagnostic Test: Quantra System with the QPlus CartridgePatients undergoing elective cardiac surgery requiring cardiopulmonary bypass. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes subjects 18 years or older undergoing cardiac surgery with cardiopulmonary bypass.
Key inclusion criteria (3 listed)
- Subject is >18 years
- Subject is undergoing elective cardiac surgery with cardiopulmonary bypass
- Subject is willing to participate and has signed a consent form
Key exclusion criteria (3 listed)
- Subject is younger than 18 years
- Subject has known congenital coagulopathy
- Subject is unable to provide written informed consent
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 System with the QPlus CartridgePoint-of-care viscoelastic testing | Diagnostic test | Cardiac surgery patients |
Primary outcome
Comparison of QPlus Clot Time and Clot Stiffness results to comparable ROTEM delta results
Time frame: Baseline (before surgery)
Coagulation function assessed by Quantra QPlus Cartridge and ROTEM delta
Comparison of QPlus Clot Time and Clot Stiffness results to comparable ROTEM delta
Time frame: After cardiac bypass (10 minutes after administration of protamine)
Coagulation function assessed by Quantra QPlus Cartridge and ROTEM delta
Comparison of QPlus Clot Time and Clot Stiffness results to standard coagulation test results
Time frame: Baseline (before surgery)
Coagulation function assessed by Quantra QPlus Cartridge and standard coagulation tests
Comparison of QPlus Clot Time and Clot Stiffness results to standard coagulation test results
Time frame: After cardiac bypass (10 minutes after administration of protamine)
Coagulation function assessed by Quantra QPlus Cartridge and standard coagulation tests
2 secondary outcomes
Comparison of QPlus Clot Stiffness results to platelet function tests with multiple electrode aggregometry (MEA): ADPtest and TRAPtest
Time frame: Baseline (before surgery)
Comparison of QPlus Clot Stiffness results to platelet function tests with multiple electrode aggregometry (MEA): ADPtest and TRAPtest
Time frame: After cardiac bypass (10 minutes after administration of protamine)
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 Sep 2018.
- 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.
Marco Ranucci, MD principal investigator
IRCCS Policlinico San Donato (Milan) Italy
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 Coagulation Disorder, run by HemoSonics LLC at 1 site in Italy.
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 Sep 2018. 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 Italy. 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?
Comparison of QPlus Clot Time and Clot Stiffness results to comparable ROTEM delta results (time frame: Baseline (before surgery)). The study lists 4 primary outcomes in all. 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 26 Sep 2018.