Blood Loss, SurgicalNCT03931031
Pre-surgical Evaluation for the Quantra System in Adult Patients Undergoing Cardiac Surgery
An observational study of Blood Loss, Surgical, run by HemoSonics LLC at 1 site in United States.
Trial summary
This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QPlus Cartridge in patients taking anitplatelet medication that are scheduled to undergo cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Loss, Surgical
- What is being tested?
- Quantra System
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2019to 27 Jun 2020
- 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: Potential study participants will be adult (≥ 18 years) subjects who are taking antiplatelet medication and who are scheduled for elective cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular assist device.
Who may be able to join
- Subject is scheduled for elective cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular assist device
- Subject was identified as taking antiplatelet medication, specifically a P2Y12 inhibitor such that a TEG Platelet Mapping test is prescribed prior to surgery to assess possible platelet inhibition
- Subject is ≥ 18 years
- Subject is willing to participate and he/she has signed a consent form
Who cannot join
- Subject is younger that 18 years
- Subject is unable to provide written informed consent
- Subject is incarcerated at the time of the study
- Subject is pregnant
- Subject is currently enrolled in a distinct study that might confound the results of the proposed study
- Subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks.
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QPlus Cartridge in patients taking anitplatelet medication that are scheduled to undergo cardiac surgery.
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 was developed to monitor hemostasis during major surgical procedures in adult patients. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding six parameters that depict the functional status of a patient's coagulation system.
This single-site, prospective, observational study will evaluate the performance of the Quantra System as compared to standard coagulation tests and comparable measures determined using TEG in patients taking antiplatelet medication that are scheduled to undergo cardiac surgery.
- Conditions
- Blood Loss, Surgical
- Being tested
- Quantra System
- Keywords
- Viscoelastic testing, Coagulation, Quantra, Hemostasis
- Medical subject headings
- Blood Loss, Surgical, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantra SystemDiagnostic test
Also called Quantra QPlus Cartridge
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Surgery Patients | Patients taking antiplatelet medication who are scheduled for elective cardiac surgery. Receives: Diagnostic Test: Quantra System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Quantra Clot Time test results to TEG test results.
Coagulation function assessed by Quantra and TEG.
Measured: Prior to surgery (Baseline)
Comparison of Quantra Clot Stiffness test results to TEG test results.
Coagulation function assessed by Quantra and TEG.
Measured: Prior to surgery (Baseline)
Comparison of Quantra Clot Time and Clot Stiffness test results to TEG test results.
Coagulation function assessed by Quantra and TEG.
Measured: Post-bypass (10 to 20 minutes after protamine administration).
Comparison of Quantra Clot Time test results to TEG test results.
Coagulation function assessed by Quantra and TEG.
Measured: Post-bypass (10 to 20 minutes after protamine administration).
Comparison of Quantra Fibrinogen Contribution to Clot Stiffness test results to laboratory fibrinogen
Coagulation function assessed by Quantra and laboratory fibrinogen testing
Measured: Prior to surgery (Baseline)
Comparison of Quantra Fibrinogen Contribution to Clot Stiffness test results to laboratory fibrinogen
Coagulation function assessed by Quantra and laboratory fibrinogen testing
Measured: Post-bypass (10 to 20 minutes after protamine administration).
Comparison of Quantra Platelet Contribution to Clot Stiffness test results to laboratory platelet count
Coagulation function assessed by Quantra and laboratory fibrinogen testing
Measured: Post-bypass (10 to 20 minutes after protamine administration).
Comparison of Quantra Platelet Contribution to Clot Stiffness test results to laboratory platelet count
Coagulation function assessed by Quantra and platelet count
Measured: Prior to surgery (Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start21 Mar 2019
- Primary completion7 Apr 2020
- Study completion27 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Loss, SurgicalStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- HemoSonics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931031
- Sponsor's protocol ID
- HEMCS-017
- Status last verified
- Jun 2020
- First submitted
- 20 Apr 2019
- Last updated
- 1 Jul 2020
- 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 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-surgical Evaluation for the Quantra System in Adult Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03931031
- Acronym / sponsor ID
- HEMCS-017
- Conditions
- Blood Loss, Surgical
- Keywords
- Viscoelastic testing, Coagulation, Quantra, Hemostasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- HemoSonics LLCIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 7 Apr 2020 (actual)
- Study completion
- 27 Jun 2020 (actual)
- First posted
- 29 Apr 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.
This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QPlus Cartridge in patients taking anitplatelet medication that are scheduled to undergo cardiac surgery.
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 was developed to monitor hemostasis during major surgical procedures in adult patients. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding six parameters that depict the functional status of a patient's coagulation system.
This single-site, prospective, observational study will evaluate the performance of the Quantra System as compared to standard coagulation tests and comparable measures determined using TEG in patients taking antiplatelet medication that are scheduled to undergo cardiac surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Surgery Patients | – | Diagnostic Test: Quantra SystemPatients taking antiplatelet medication who are scheduled for elective cardiac surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential study participants will be adult (≥ 18 years) subjects who are taking antiplatelet medication and who are scheduled for elective cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular assist device.
Key inclusion criteria (4 listed)
- Subject is scheduled for elective cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular assist device
- Subject was identified as taking antiplatelet medication, specifically a P2Y12 inhibitor such that a TEG Platelet Mapping test is prescribed prior to surgery to assess possible platelet inhibition
- Subject is ≥ 18 years
- Subject is willing to participate and he/she has signed a consent form
Key exclusion criteria (6 listed)
- Subject is younger that 18 years
- Subject is unable to provide written informed consent
- Subject is incarcerated at the time of the study
- Subject is pregnant
- Subject is currently enrolled in a distinct study that might confound the results of the proposed study
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 SystemAlso: Quantra QPlus CartridgeDiagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care | Diagnostic test | Cardiac Surgery Patients |
Primary outcome
Comparison of Quantra Clot Time test results to TEG test results.
Time frame: Prior to surgery (Baseline)
Coagulation function assessed by Quantra and TEG.
Comparison of Quantra Clot Stiffness test results to TEG test results.
Time frame: Prior to surgery (Baseline)
Coagulation function assessed by Quantra and TEG.
Comparison of Quantra Clot Time and Clot Stiffness test results to TEG test results.
Time frame: Post-bypass (10 to 20 minutes after protamine administration).
Coagulation function assessed by Quantra and TEG.
Comparison of Quantra Clot Time test results to TEG test results.
Time frame: Post-bypass (10 to 20 minutes after protamine administration).
Coagulation function assessed by Quantra and TEG.
Comparison of Quantra Fibrinogen Contribution to Clot Stiffness test results to laboratory fibrinogen
Time frame: Prior to surgery (Baseline)
Coagulation function assessed by Quantra and laboratory fibrinogen testing
Comparison of Quantra Fibrinogen Contribution to Clot Stiffness test results to laboratory fibrinogen
Time frame: Post-bypass (10 to 20 minutes after protamine administration).
Coagulation function assessed by Quantra and laboratory fibrinogen testing
Comparison of Quantra Platelet Contribution to Clot Stiffness test results to laboratory platelet count
Time frame: Post-bypass (10 to 20 minutes after protamine administration).
Coagulation function assessed by Quantra and laboratory fibrinogen testing
Comparison of Quantra Platelet Contribution to Clot Stiffness test results to laboratory platelet count
Time frame: Prior to surgery (Baseline)
Coagulation function assessed by Quantra and platelet count
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 1 Jul 2020.
- 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.
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 Blood Loss, Surgical, run by HemoSonics LLC at 1 site in United States.
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 4 inclusion and 6 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 1 Jul 2020. 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 United States. 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 Quantra Clot Time test results to TEG test results. (time frame: Prior to surgery (Baseline)). The study lists 8 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 1 Jul 2020.