TraumaNCT05376462
Quantra® System With the QStat® Cartridge in Trauma
An observational study of Trauma and Coagulation Defect; Bleeding, run by HemoSonics LLC at 1 site in France.
Trial summary
This is a prospective, single-center, observational study to assess the Quantra QStat System in trauma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Coagulation Defect; Bleeding
- What is being tested?
- Quantra System with the QStat Cartridge
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 12 Apr 2022to 1 Jan 2024
- 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: Trauma patients requiring a full trauma team response.
Who may be able to join
- Subject is > 18 years; Children under the age of 18 are protected by adults under guardianship or by court order.
- Subject is a trauma patient experiencing traumatic injuries requiring a full trauma team response according to site's level 1of trauma team activation criteria.
- Subject, or subject's legally authorized representative (LAR), is willing to provide informed consent, either prospectively or by deferred consent.
Who cannot join
- Subject is pregnant.
- Subject is currently enrolled in a distinct study that might confound the result of the proposed study.
- Subject is not covered by social security.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Interventional Randomized Controlled Trial of the Quantra® System With the QStat® Cartridge in Trauma
This is a prospective, single-center, observational study to assess the Quantra QStat System in trauma patients.
Read the detailed description
This is a prospective, single-center, observational study to assess the performance of the Quantra QStat System in trauma patients.
- Conditions
- Trauma, Coagulation Defect; Bleeding
- Being tested
- Quantra System with the QStat Cartridge
- Keywords
- Quantra, QStat, Viscoelastic testing
- Medical subject headings
- Wounds and Injuries, Hemostatic Disorders, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantra System with the QStat CartridgeDiagnostic test
Whole blood viscoelastic test system that provides an assessment of the patient's coagulation status.
| Study group | Role | What they receive |
|---|---|---|
| Quantra System with the QStat Cartridge | Viscoelastic testing using the Quantra System with the QStat Cartridge. Receives: Diagnostic Test: Quantra System with the QStat Cartridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total units of red blood cells (RBC) transfused
The primary endpoint of Phase II will be the total units of red blood cells (RBC) transfused and administered 24 hours post-presentation for trauma subjects.
Measured: 24 hours post-presentation for trauma subjects
Secondary outcomes (1)
Total number of units (cc) of platelets, fibrinogen, fresh frozen plasma and TXA transfused
Total number of units (cc) of platelets, fibrinogen, fresh frozen plasma and TXA administered within at 48 hrs after admission to the hospital.
Measured: 48 hours after admission to the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start12 Apr 2022
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Why it stopped: Only Phase 1 (observational) completed. Did not proceed to Phase 2 due to site time constraints/competing priorities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- HemoSonics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Lille
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376462
- Sponsor's protocol ID
- HEMCS-039
- Status last verified
- Mar 2025
- First submitted
- 11 May 2022
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share individual data.
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional Randomized Controlled Trial of the Quantra® System With the QStat® Cartridge in Trauma
- ClinicalTrials.gov ID
- NCT05376462
- Acronym / sponsor ID
- HEMCS-039
- Conditions
- Trauma, Coagulation Defect; Bleeding
- Keywords
- Quantra, QStat, Viscoelastic testing
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Only Phase 1 (observational) completed. Did not proceed to Phase 2 due to site time constraints/competing priorities.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- HemoSonics LLCIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Lille
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 17 May 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 prospective, single-center, observational study to assess the Quantra QStat System in trauma patients.
Detailed description
This is a prospective, single-center, observational study to assess the performance of the Quantra QStat System in trauma patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quantra System with the QStat Cartridge | – | Diagnostic Test: Quantra System with the QStat CartridgeViscoelastic testing using the Quantra System with the QStat Cartridge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Trauma patients requiring a full trauma team response.
Key inclusion criteria (3 listed)
- Subject is > 18 years; Children under the age of 18 are protected by adults under guardianship or by court order.
- Subject is a trauma patient experiencing traumatic injuries requiring a full trauma team response according to site's level 1of trauma team activation criteria.
- Subject, or subject's legally authorized representative (LAR), is willing to provide informed consent, either prospectively or by deferred consent.
Key exclusion criteria (3 listed)
- Subject is pregnant.
- Subject is currently enrolled in a distinct study that might confound the result of the proposed study.
- Subject is not covered by social security.
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 System with the QStat CartridgeWhole blood viscoelastic test system that provides an assessment of the patient's coagulation status. | Diagnostic test | Quantra System with the QStat Cartridge |
Primary outcome
Total units of red blood cells (RBC) transfused
Time frame: 24 hours post-presentation for trauma subjects
The primary endpoint of Phase II will be the total units of red blood cells (RBC) transfused and administered 24 hours post-presentation for trauma subjects.
1 secondary outcome
Total number of units (cc) of platelets, fibrinogen, fresh frozen plasma and TXA transfused
Time frame: 48 hours after admission to the hospital
Results and safety
The study was stopped early (reason given: Only Phase 1 (observational) completed. Did not proceed to Phase 2 due to site time constraints/competing priorities.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: No. No plan to share individual data.
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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 Trauma and Coagulation Defect; Bleeding, run by HemoSonics LLC at 1 site in France.
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: stopped early, as of the sponsor's last update on 14 Mar 2025. 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 France. 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 was stopped early (reason given: Only Phase 1 (observational) completed. Did not proceed to Phase 2 due to site time constraints/competing priorities.). Results are not available in the source record.
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?
Total units of red blood cells (RBC) transfused (time frame: 24 hours post-presentation for trauma subjects). 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 14 Mar 2025.