Coagulation Defect; BleedingNCT05290675
Quantra QPlus Sample Type Comparison
An observational study of Coagulation Defect; Bleeding, run by HemoSonics LLC at 1 site in United States.
Trial summary
This is a single center prospective observational study to compare QPlus parameter measurements in arterial and venous blood samples collected in parallel from patients undergoing cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coagulation Defect; Bleeding
- What is being tested?
- Quantra QPlus System
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2021to 2 Nov 2022
- 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: Adult males and females undergoing cardiac surgery
Who may be able to join
- Subject is scheduled for cardiac surgery, utilizing cardiopulmonary bypass, or including placement of a ventricular assist device
- Subject is ≥18 years
- Subject or subject's legally authorized representative is willing to participate and he/she has signed a consent formr.
Who cannot join
- Subject is younger than 18 years
- Subject is pregnant
- Subject is incarcerated at the time of the study
- Subject is affected by a condition that, in the opinion of the surgical team, may pose additional risks
- Subject, or subject's legally aurthorized representative is able to provide written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Official title: Impact of Sample Type and Assay Time on the Performance of the Quantra QPlus System
This is a single center prospective observational study to compare QPlus parameter measurements in arterial and venous blood samples collected in parallel from patients undergoing cardiac surgery.
Read the detailed description
In this single center prospective observational study, 40 cardiac surgery subjects will enrolled, each with parallel artrial and venous samples collected at 3 time points to yield 120 matched samples for analysis on the Quantra System with the QPlus Cartridge.
- Conditions
- Coagulation Defect; Bleeding
- Being tested
- Quantra QPlus System
- Keywords
- Cardiac surgery, Quantra, Viscoelastic testing, Coagulation
- Medical subject headings
- Hemostatic Disorders, Hemorrhage, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantra QPlus SystemDiagnostic test
Whole blood coagulation testing system
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of QPlus Clot time (CT) in arterial and venous samples
Coagulation function assessed in two sample types
Measured: During cardiac surgery
Comparison of QPlus Clot time with Heparinase (CTH) in arterial and venous samples
Coagulation function assessed in two sample types
Measured: During cardiac surgery
Comparison of Clot stiffness (CS) determined with Quantra QPlus Cartridge in arterial and venous samples
Measure of the overall shear modulus or strength/quality of the clot determined using SEER sonorheometry assessed in two sample types
Measured: During cardiac surgery
Comparison of QPlus Platelet Contribution to Clot stiffness (PCS) in arterial and venous samples
Measure of the shear modulus or strength/quality of the clot contributed by platelets determined using SEER sonorheometry assessed in two sample types
Measured: During cardiac surgery
Comparison of QPlus Fibrinogen Contribution to Clot stiffness (FCS) in arterial and venous samples
Measure of the shear modulus or strength/quality of the clot contributed by fibrinogen determined using SEER sonorheometry assessed in two sample types
Measured: During cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start4 Nov 2021
- Primary completion31 Aug 2022
- Study completion2 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coagulation Defect; BleedingStudies 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
- 50 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
- NCT05290675
- Sponsor's protocol ID
- HEMCS-042
- Status last verified
- Apr 2023
- First submitted
- 13 Jan 2022
- Last updated
- 1 May 2023
- 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 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sample Type and Assay Time on the Performance of the Quantra QPlus System
- ClinicalTrials.gov ID
- NCT05290675
- Acronym / sponsor ID
- HEMCS-042
- Conditions
- Coagulation Defect; Bleeding
- Keywords
- Cardiac surgery, Quantra, Viscoelastic testing, Coagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- HemoSonics LLCIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 2 Nov 2022 (actual)
- First posted
- 22 Mar 2022 (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 is a single center prospective observational study to compare QPlus parameter measurements in arterial and venous blood samples collected in parallel from patients undergoing cardiac surgery.
Detailed description
In this single center prospective observational study, 40 cardiac surgery subjects will enrolled, each with parallel artrial and venous samples collected at 3 time points to yield 120 matched samples for analysis on the Quantra System with the QPlus Cartridge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult males and females undergoing cardiac surgery
Key inclusion criteria (3 listed)
- Subject is scheduled for cardiac surgery, utilizing cardiopulmonary bypass, or including placement of a ventricular assist device
- Subject is ≥18 years
- Subject or subject's legally authorized representative is willing to participate and he/she has signed a consent formr.
Key exclusion criteria (5 listed)
- Subject is younger than 18 years
- Subject is pregnant
- Subject is incarcerated at the time of the study
- Subject is affected by a condition that, in the opinion of the surgical team, may pose additional risks
- Subject, or subject's legally aurthorized representative is able 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 QPlus SystemWhole blood coagulation testing system | Diagnostic test | – |
Primary outcome
Comparison of QPlus Clot time (CT) in arterial and venous samples
Time frame: During cardiac surgery
Coagulation function assessed in two sample types
Comparison of QPlus Clot time with Heparinase (CTH) in arterial and venous samples
Time frame: During cardiac surgery
Coagulation function assessed in two sample types
Comparison of Clot stiffness (CS) determined with Quantra QPlus Cartridge in arterial and venous samples
Time frame: During cardiac surgery
Measure of the overall shear modulus or strength/quality of the clot determined using SEER sonorheometry assessed in two sample types
Comparison of QPlus Platelet Contribution to Clot stiffness (PCS) in arterial and venous samples
Time frame: During cardiac surgery
Measure of the shear modulus or strength/quality of the clot contributed by platelets determined using SEER sonorheometry assessed in two sample types
Comparison of QPlus Fibrinogen Contribution to Clot stiffness (FCS) in arterial and venous samples
Time frame: During cardiac surgery
Measure of the shear modulus or strength/quality of the clot contributed by fibrinogen determined using SEER sonorheometry assessed in two sample types
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 May 2023.
- 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 Coagulation Defect; Bleeding, 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 3 inclusion and 5 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 May 2023. 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 QPlus Clot time (CT) in arterial and venous samples (time frame: During cardiac surgery). The study lists 5 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 May 2023.