Blood Loss, SurgicalNCT07597278
Quantra QPlus in Pediatric Cardiovascular Procedures
An observational study of Blood Loss, Surgical, run by HemoSonics LLC at 3 sites in United States.
Trial summary
This study will evaluate the performance of the Quantra System with the QPlus Cartridge in pediatric patients undergoing cardiovascular procedures. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Blood Loss, Surgical
- What is being tested?
- Quantra System
- How many people
- 160 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Jun 2027to 15 Oct 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population includes pediatric patients <18 years of age that are undergoing cardiovascular procedures.
Who may be able to join
- Subject is <18 years of age.
- Subject is undergoing a cardiovascular procedure OR subject underwent cardiovascular surgery and presents with acute bleeding or suspected hypocoagulation/hypercoagulation in a post-surgical unit.
- Subject's parent(s) or guardian(s) has signed an informed consent form. If required, subject has signed an assent form.
Who cannot join
- Corrected gestational age <37 weeks.
- Subject is enrolled in a study that might confound the result 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
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
UCLA Mattel Children's Hospital
Los Angeles, California, 90095
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Evaluation of the Clinical Performance of the Quantra System With the QPlus Cartridge in Pediatric Patients Undergoing Cardiovascular Procedures
This study will evaluate the performance of the Quantra System with the QPlus Cartridge in pediatric patients undergoing cardiovascular procedures.
Read the detailed description
Pediatric patients that require major sugical procedures, such as cardiac surgery, are especially vulnerable to perioperative coagulopathy due to age-related immaturity of the hemostatic system, exposure to hemodilution from circuit primes or intravenous volume loading, hypothermia during complex interventions, and the intrinsic bleeding of invasive cardiac procedures. These factors can produce clinically significant perioperative bleeding driven by platelet dysfunction, hypofibrinogenemia and other hemostatic defects. The Quantra System with the QPlus Cartridge is desinged to assess coagulation function of a whole blood sample at the point-of-care by measuring changes in the viscoelastic properties during clot formation. This multi-center study is aimed to demonstrate the performance of the QPlus Cartridge for its ability to aid in the evaluation of a pediatric patient's hemostatic status before, during and after cardiovascular procedures.
- Conditions
- Blood Loss, Surgical
- Being tested
- Quantra System
- Keywords
- Viscoelastic testing, Quantra, QPlus Cartridge, Pediatric, Cardiovascular surgery
- Medical subject headings
- Blood Loss, Surgical
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 the coagulation properties of a whole blood sample at the point-of-care.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients | Pediatric patients undergoing cardiovascular procedures Receives: Diagnostic Test: Quantra System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of QPlus CT measurements to ROTEM Sigma INTEM CT
Coagulation function assessed by Quantra and ROTEM sigma
Measured: 3 TIme Points: 1. 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
Correlation of QPlus CTH measurements to ROTEM Sigma HEPTEM CT
Coagulation function assessed by Quantra and ROTEM sigma
Measured: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
Correlation of QPlus CS measurements to ROTEM Sigma EXTEM A10
Coagulation function assessed by Quantra and ROTEM sigma
Measured: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
Correlation of QPlus FCS measurements to ROTEM Sigma FIBTEM A10
Coagulation function assessed by Quantra and ROTEM sigma
Measured: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
Correlation of QPlus CT to TEG 6S CK-R
Coagulation function assessed by Quantra and TEG 6S
Measured: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
Correlation of QPlus CTH to TEG 6S CKH-R
Coagulation function assessed by Quantra and TEG 6S
Measured: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
Correlation of QPlus CS to TEG 6S CKH-MA
Coagulation function assessed by Quantra and TEG 6S
Measured: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
Correlation of QPlus FCS to TEG 6S FFH-MA
Coagulation function assessed by Quantra and TEG 6S
Measured: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start25 Jun 2027 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion15 Oct 2028 (estimated)
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
- 160 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
- NCT07597278
- Sponsor's protocol ID
- HEMCS-051
- Status last verified
- Sep 2026
- First submitted
- 12 May 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: Data sharing agreements prevent sharing of IPD.
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
- Evaluation of the Clinical Performance of the Quantra System With the QPlus Cartridge in Pediatric Patients Undergoing Cardiovascular Procedures
- ClinicalTrials.gov ID
- NCT07597278
- Acronym / sponsor ID
- HEMCS-051
- Conditions
- Blood Loss, Surgical
- Keywords
- Viscoelastic testing, Quantra, QPlus Cartridge, Pediatric, Cardiovascular surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- HemoSonics LLCIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2027 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 15 Oct 2028 (estimated)
- First posted
- 19 May 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 evaluate the performance of the Quantra System with the QPlus Cartridge in pediatric patients undergoing cardiovascular procedures.
Detailed description
Pediatric patients that require major sugical procedures, such as cardiac surgery, are especially vulnerable to perioperative coagulopathy due to age-related immaturity of the hemostatic system, exposure to hemodilution from circuit primes or intravenous volume loading, hypothermia during complex interventions, and the intrinsic bleeding of invasive cardiac procedures. These factors can produce clinically significant perioperative bleeding driven by platelet dysfunction, hypofibrinogenemia and other hemostatic defects. The Quantra System with the QPlus Cartridge is desinged to assess coagulation function of a whole blood sample at the point-of-care by measuring changes in the viscoelastic properties during clot formation. This multi-center study is aimed to demonstrate the performance of the QPlus Cartridge for its ability to aid in the evaluation of a pediatric patient's hemostatic status before, during and after cardiovascular procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients | – | Diagnostic Test: Quantra SystemPediatric patients undergoing cardiovascular procedures |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population includes pediatric patients <18 years of age that are undergoing cardiovascular procedures.
Key inclusion criteria (3 listed)
- Subject is <18 years of age.
- Subject is undergoing a cardiovascular procedure OR subject underwent cardiovascular surgery and presents with acute bleeding or suspected hypocoagulation/hypercoagulation in a post-surgical unit.
- Subject's parent(s) or guardian(s) has signed an informed consent form. If required, subject has signed an assent form.
Key exclusion criteria (3 listed)
- Corrected gestational age <37 weeks.
- Subject is enrolled in a study that might confound the result of the proposed study.
- Subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks.
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 the coagulation properties of a whole blood sample at the point-of-care. | Diagnostic test | Pediatric patients |
Primary outcome
Correlation of QPlus CT measurements to ROTEM Sigma INTEM CT
Time frame: 3 TIme Points: 1. 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
Coagulation function assessed by Quantra and ROTEM sigma
Correlation of QPlus CTH measurements to ROTEM Sigma HEPTEM CT
Time frame: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
Coagulation function assessed by Quantra and ROTEM sigma
Correlation of QPlus CS measurements to ROTEM Sigma EXTEM A10
Time frame: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
Coagulation function assessed by Quantra and ROTEM sigma
Correlation of QPlus FCS measurements to ROTEM Sigma FIBTEM A10
Time frame: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
Coagulation function assessed by Quantra and ROTEM sigma
Correlation of QPlus CT to TEG 6S CK-R
Time frame: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
Coagulation function assessed by Quantra and TEG 6S
Correlation of QPlus CTH to TEG 6S CKH-R
Time frame: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
Coagulation function assessed by Quantra and TEG 6S
Correlation of QPlus CS to TEG 6S CKH-MA
Time frame: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
Coagulation function assessed by Quantra and TEG 6S
Correlation of QPlus FCS to TEG 6S FFH-MA
Time frame: 3 TIme Points: 1.Preoperatively, 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.
Coagulation function assessed by Quantra and TEG 6S
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. Data sharing agreements prevent sharing of IPD.
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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.
3 sites 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 3 sites 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 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: 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 3 sites 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?
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 (9192446990, dwinegar@hemosonics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of QPlus CT measurements to ROTEM Sigma INTEM CT (time frame: 3 TIme Points: 1. 2.During the procedure, and 3.Postoperatively within 24 hours of the end of the procedure.). 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 17 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.