PediatricNCT07447713
Reference Range Study for the Quantra System With the QPlus Cartridge in Pediatric Patients
An observational study of Pediatric and Coagulation, run by HemoSonics LLC at 4 sites in 2 countries.
Trial summary
This study will determine reference range intervals for the parameters reported by the Quantra System with the QPlus Cartridge in pediatric patients. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Pediatric, Coagulation
- What is being tested?
- Quantra System
- How many people
- 240 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 15 Mar 2027to 30 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 17 years
- All sexes
- Child
Study population: Children, age birth to <18 years of age, scheduled for a procedure requiring anesthesia in which vascular access would routinely be placed.
Who may be able to join
- Subject is <18 years of age
- Corrected gestational age ≥ 37weeks
- Subject is scheduled for an elective surgery, non-surgical intervention or diagnostic procedure requiring anesthesia and vascular access with an ASA score ≤3.
- Subject's parent or guardian has signed an informed consent form. If required, subject has signed an assent form.
Who cannot join
- Subject is hospitalized in the Pediatric Intensive Care Unit
- Subject requires Extracorporeal Membrane Oxygenation (ECMO)
- Subject has had an infection within 7 days of the scheduled procedure
- Subject has an active coagulation disorder (bleeding or thrombosis)
- For subjects that have a hemoglobin measurement within 24 hours of the scheduled procedure, hemoglobin is <8g/dL or >16g/dL
- Subject has a baseline oxygen saturation <92%
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United States3 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
Department of Anesthesiology
Boston Children's Hospital
Boston, Massachusetts, 02115
Department of Anesthesiology
UCLA Mattel Children's Hospital
Los Angeles, California, 90095
Department of Anesthesiology
Switzerland1 site
University Children's Hospital Zurich
Zurich, 8008
Department of Anesthesiology
About this study
This study will determine reference range intervals for the parameters reported by the Quantra System with the QPlus Cartridge in pediatric patients.
Read the detailed description
The hemostatic profile of an infant is different than that of an adult and changes with age. Most differences occur within the first 6 months of age, with coagulation function similar to that of an adult within the first year of life. To assess the clinical utility of the Quantra System in pediatric patients that are bleeding or at risk for bleeding, it is important to understand the normal reference intervals for the parameters reported by the QPlus Cartridge in normal, healthy pediatric patients.
- Conditions
- Pediatric, Coagulation
- Being tested
- Quantra System
- Keywords
- Reference range, Quantra QPlus
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantra SystemDiagnostic test
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients | Not described 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 for CT in pediatric patients
Measured: Baseline, determined from a single blood draw
Reference range intervals for measurement of Clot Time with Heparinase (CTH) parameter
Reference range intervals for CTH in pediatric patients
Measured: Baseline, determined from a single blood draw.
Reference range intervals for measurement of Clot Stiffness (CS) parameter
Reference range intervals for CS in pediatric patients
Measured: Baseline, determined from a single blood draw
Reference range intervals for measurement of Fibrinogen Contribution (FCS) parameter
Reference range intervals for FCS in pediatric patients
Measured: Baseline, determined from a single blood draw
Reference range intervals for measurement of Platelet Contribution (PCS) parameter
Reference range intervals for PCS in pediatric patients
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 posted3 Mar 2026
- Study start15 Mar 2027 (estimated)
- Primary completion30 Jan 2028 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediatricStudies 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HemoSonics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447713
- Sponsor's protocol ID
- HEMCS-050
- Status last verified
- Sep 2026
- First submitted
- 26 Feb 2026
- Last updated
- 17 Sep 2026
- 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 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reference Range Study for the Quantra System With the QPlus Cartridge in Pediatric Patients
- ClinicalTrials.gov ID
- NCT07447713
- Acronym / sponsor ID
- HEMCS-050
- Conditions
- Pediatric, Coagulation
- Keywords
- Reference range, Quantra QPlus
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- HemoSonics LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2027 (estimated)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 3 Mar 2026 (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 determine reference range intervals for the parameters reported by the Quantra System with the QPlus Cartridge in pediatric patients.
Detailed description
The hemostatic profile of an infant is different than that of an adult and changes with age. Most differences occur within the first 6 months of age, with coagulation function similar to that of an adult within the first year of life. To assess the clinical utility of the Quantra System in pediatric patients that are bleeding or at risk for bleeding, it is important to understand the normal reference intervals for the parameters reported by the QPlus Cartridge in normal, healthy pediatric patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients | – | Diagnostic Test: Quantra System |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- Children, age birth to <18 years of age, scheduled for a procedure requiring anesthesia in which vascular access would routinely be placed.
Key inclusion criteria (4 listed)
- Subject is <18 years of age
- Corrected gestational age ≥ 37weeks
- Subject is scheduled for an elective surgery, non-surgical intervention or diagnostic procedure requiring anesthesia and vascular access with an ASA score ≤3.
- Subject's parent or guardian has signed an informed consent form. If required, subject has signed an assent form.
Key exclusion criteria (6 listed)
- Subject is hospitalized in the Pediatric Intensive Care Unit
- Subject requires Extracorporeal Membrane Oxygenation (ECMO)
- Subject has had an infection within 7 days of the scheduled procedure
- Subject has an active coagulation disorder (bleeding or thrombosis)
- For subjects that have a hemoglobin measurement within 24 hours of the scheduled procedure, hemoglobin is <8g/dL or >16g/dL
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 SystemDiagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care. | Diagnostic test | Pediatric patients |
Primary outcome
Reference range intervals for measurement of Clot Time (CT) parameter
Time frame: Baseline, determined from a single blood draw
Reference range intervals for CT in pediatric patients
Reference range intervals for measurement of Clot Time with Heparinase (CTH) parameter
Time frame: Baseline, determined from a single blood draw.
Reference range intervals for CTH in pediatric patients
Reference range intervals for measurement of Clot Stiffness (CS) parameter
Time frame: Baseline, determined from a single blood draw
Reference range intervals for CS in pediatric patients
Reference range intervals for measurement of Fibrinogen Contribution (FCS) parameter
Time frame: Baseline, determined from a single blood draw
Reference range intervals for FCS in pediatric patients
Reference range intervals for measurement of Platelet Contribution (PCS) parameter
Time frame: Baseline, determined from a single blood draw
Reference range intervals for PCS in pediatric patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- 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.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric and Coagulation, run by HemoSonics LLC at 4 sites in 2 countries.
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: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deborah Winegar, PhD (19192446990, dwinegar@hemosonics.com), or a site near the patient. 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 17 Sep 2026.