Coagulation DisorderNCT04490759
QStat Pilot Reference Range Study
An observational study of Coagulation Disorder, run by HemoSonics LLC at 1 site in United States.
Trial summary
The objective is to determine the initial reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coagulation Disorder
- What is being tested?
- Quantra System
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2018to 16 Jul 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult volunteers with normal coagulation function, approximately equal numbers of males and females across three age group categories (18-30, 31-50 and >50 years). The racial and ethnic profiles will be representative of the populations at the site.
Who may be able to join
- Subject is 18 years or older
- Subject is willing to participate and has signed a consent form
- Subject's laboratory coagulation test results at screening are within each test's normal reference range.
Who cannot join
- Subject is younger than 18 years
- Subject has a history of a coagulation disorder
- Subject is pregnant or lactating
- Subject is currently taking medications known to alter coagulation
- Subject has one or more laboratory coagulation test restuls outside of the normal reference range at screening
- Subject had a blood transfusion or surgery within the last month
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- Drug abuse
- Excessive alcohol consumption
- Subject is unable to provide written informed consent
- Subject is incarcerated at the time of the study
- Subject previously participated in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reference Range Pilot Study for the Quantra Analyzer With the QStat Cartridge
The objective is to determine the initial reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge.
Read the detailed description
This is a single center prospective, observational study of a healthy adult population with normal coagulation function to determine the initial reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge. The threshold for the Clot Stability to Lysis (CSL) parameter will be determined from the CSL reference range.
- Conditions
- Coagulation Disorder
- Being tested
- Quantra System
- 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 SystemDiagnostic test
Also called QStat Cartridge
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Blood samples from healthy volunteers analyzed on the Quantra System Receives: Diagnostic Test: Quantra System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reference range intervals for measurement of Clot Time (CT) parameter
Reference range intervals determined in this study will serve as the reference range for CT on the QStat Cartridge when it is commercially available.
Measured: Baseline, determined from a single blood draw
Reference range intervals for measurement of Clot Stiffness (CS) parameter
Reference range intervals determined in this study will serve as the reference range for CS on the QStat Cartridge when it is commercially available.
Measured: Baseline, determined from a single blood draw
Reference range intervals for measurement of Fibrinogen Contribution to Clot Stiffness (FCS) parameter
Reference range intervals determined in this study will serve as the reference range for FCS on the QStat Cartridge when it is commercially available.
Measured: Baseline, determined from a single blood draw
Reference range intervals for measurement of Platelet Contribution to Clot Stiffness (PCS) parameter
Reference range intervals determined in this study will serve as the reference range for PCS on the QStat Cartridge when it is commercially available.
Measured: Baseline, determined from a single blood draw
Reference range intervals for measurement of Clot Stability to Lysis (CSL) parameter
Reference range intervals determined in this study will serve as the reference range for CSL on the QStat Cartridge when it is commercially available.
Measured: Baseline, determined from a single blood draw
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start29 Nov 2018
- Primary completion4 Dec 2018
- Study completion16 Jul 2019
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
- 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
- NCT04490759
- Sponsor's protocol ID
- HEMCS-020
- Status last verified
- Jul 2020
- First submitted
- 24 Jul 2020
- Last updated
- 29 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 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reference Range Pilot Study for the Quantra Analyzer With the QStat Cartridge
- ClinicalTrials.gov ID
- NCT04490759
- Acronym / sponsor ID
- HEMCS-020
- Conditions
- Coagulation Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- HemoSonics LLCIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 4 Dec 2018 (actual)
- Study completion
- 16 Jul 2019 (actual)
- First posted
- 29 Jul 2020 (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.
The objective is to determine the initial reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge.
Detailed description
This is a single center prospective, observational study of a healthy adult population with normal coagulation function to determine the initial reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge. The threshold for the Clot Stability to Lysis (CSL) parameter will be determined from the CSL reference range.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Diagnostic Test: Quantra SystemBlood samples from healthy volunteers analyzed on the Quantra System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult volunteers with normal coagulation function, approximately equal numbers of males and females across three age group categories (18-30, 31-50 and >50 years). The racial and ethnic profiles will be representative of the populations at the site.
Key inclusion criteria (3 listed)
- Subject is 18 years or older
- Subject is willing to participate and has signed a consent form
- Subject's laboratory coagulation test results at screening are within each test's normal reference range.
Key exclusion criteria (11 listed)
- Subject is younger than 18 years
- Subject has a history of a coagulation disorder
- Subject is pregnant or lactating
- Subject is currently taking medications known to alter coagulation
- Subject has one or more laboratory coagulation test restuls outside of the normal reference range at screening
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: QStat CartridgeDiagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care. | Diagnostic test | Healthy volunteers |
Primary outcome
Reference range intervals for measurement of Clot Time (CT) parameter
Time frame: Baseline, determined from a single blood draw
Reference range intervals determined in this study will serve as the reference range for CT on the QStat Cartridge when it is commercially available.
Reference range intervals for measurement of Clot Stiffness (CS) parameter
Time frame: Baseline, determined from a single blood draw
Reference range intervals determined in this study will serve as the reference range for CS on the QStat Cartridge when it is commercially available.
Reference range intervals for measurement of Fibrinogen Contribution to Clot Stiffness (FCS) parameter
Time frame: Baseline, determined from a single blood draw
Reference range intervals determined in this study will serve as the reference range for FCS on the QStat Cartridge when it is commercially available.
Reference range intervals for measurement of Platelet Contribution to Clot Stiffness (PCS) parameter
Time frame: Baseline, determined from a single blood draw
Reference range intervals determined in this study will serve as the reference range for PCS on the QStat Cartridge when it is commercially available.
Reference range intervals for measurement of Clot Stability to Lysis (CSL) parameter
Time frame: Baseline, determined from a single blood draw
Reference range intervals determined in this study will serve as the reference range for CSL on the QStat Cartridge when it is commercially available.
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 29 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 Coagulation Disorder, 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 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: finished, as of the sponsor's last update on 29 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?
Reference range intervals for measurement of Clot Time (CT) parameter (time frame: Baseline, determined from a single blood draw). 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 29 Jul 2020.