Blood LossNCT05426564
Exploratory Assessment of the Quantra® System in Adult ECMO Patients
An observational study of Blood Loss and Thrombosis, run by HemoSonics LLC at 1 site in United States.
Trial summary
This is a prospective, observational exploratory study of the performance of the Quantra System in adult patients that are undergoing an arterio-venous (AV), veno-venous (VV) ECMO or extra-corporeal life support (ECLS) procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Loss, Thrombosis, Extracorporeal Circulation; Complications
- What is being tested?
- Quantra System
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2022to 1 Jun 2023
- 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: Patients undergoing arterio-venous (AV), veno-venous (VV) ECMO or extra-corporeal life support (ECLS) procedure. Both COVID-19 and non-COVID-19 related ECMO patients will be enrolled
Who may be able to join
- Subject is > 18 years.
- Subject is scheduled to undergo either VA or VV ECMO procedure or has been placed on VA or VV ECMO within 24 hours.
- 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 younger than 18 years of age.
- Subject is pregnant.
- Subject is incarcerated at the time of the study.
- Subject, or subject's legally authorized representative is unable or unwilling to provide informed consent.
- Subject is affected by a condition that, in the opinion of the treatment team, may pose additional risks.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Irvine
Irvine, California, 92697
About this study
Official title: Exploratory Assessment of the Quantra® System With the QPlus® and QStat® Cartridges in Adult ECMO Patients
This is a prospective, observational exploratory study of the performance of the Quantra System in adult patients that are undergoing an arterio-venous (AV), veno-venous (VV) ECMO or extra-corporeal life support (ECLS) procedure.
Read the detailed description
Patients 18 years or older that are undergoing an arterio-venous (AV), veno-venous (VV) ECMO or extra-corporeal life support (ECLS) procedure will be enrolled in this prospective, observational exploratory study. From each enrolled subject, blood samples will be collected at multiple time points for analysis on the Quantra QPlus or QStat Cartridge in parallel with other assessments performed as standard of care.
- Being tested
- Quantra System
- Keywords
- Quantra, ECMO, QPlus, Viscoelastic testing, Coagulation
- Medical subject headings
- Hemorrhage, 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 |
|---|---|---|
| ECMO Patients | Patients undergoing an ECMO procedure Receives: Diagnostic Test: Quantra System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Quantra Clot Time results to standard coagulation test results.
Coagulation function assessed by Quantra and standard-of-care coagulation tests
Measured: At the start of ECMO (considered the Baseline timepoint)
Comparison of Quantra Clot Stiffness results to standard coagulation test results.
Coagulation function assessed by Quantra and standard-of-care coagulation tests
Measured: At the start of ECMO (considered the Baseline timepoint)
Comparison of Quantra Clot Time results to standard coagulation test results.
Coagulation function assessed by Quantra and standard-of-care coagulation tests
Measured: 6 hours after the previous measurment
Comparison of Quantra Clot Stiffness results to standard coagulation test results.
Coagulation function assessed by Quantra and standard-of-care coagulation tests
Measured: 6 hours after the previous measurment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start27 Sep 2022
- Primary completion17 May 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood LossStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- HemoSonics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, Irvine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426564
- Sponsor's protocol ID
- HEMCS-041
- Status last verified
- Jun 2023
- First submitted
- 7 Jun 2022
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Assessment of the Quantra® System With the QPlus® and QStat® Cartridges in Adult ECMO Patients
- ClinicalTrials.gov ID
- NCT05426564
- Acronym / sponsor ID
- HEMCS-041
- Keywords
- Quantra, ECMO, QPlus, Viscoelastic testing, Coagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- HemoSonics LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of California, Irvine
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 17 May 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 22 Jun 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, observational exploratory study of the performance of the Quantra System in adult patients that are undergoing an arterio-venous (AV), veno-venous (VV) ECMO or extra-corporeal life support (ECLS) procedure.
Detailed description
Patients 18 years or older that are undergoing an arterio-venous (AV), veno-venous (VV) ECMO or extra-corporeal life support (ECLS) procedure will be enrolled in this prospective, observational exploratory study. From each enrolled subject, blood samples will be collected at multiple time points for analysis on the Quantra QPlus or QStat Cartridge in parallel with other assessments performed as standard of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECMO Patients | – | Diagnostic Test: Quantra SystemPatients undergoing an ECMO procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing arterio-venous (AV), veno-venous (VV) ECMO or extra-corporeal life support (ECLS) procedure. Both COVID-19 and non-COVID-19 related ECMO patients will be enrolled
Key inclusion criteria (3 listed)
- Subject is > 18 years.
- Subject is scheduled to undergo either VA or VV ECMO procedure or has been placed on VA or VV ECMO within 24 hours.
- Subject or subject's legally authorized representative (LAR) is willing to provide informed consent, either prospectively or by deferred consent.
Key exclusion criteria (5 listed)
- Subject is younger than 18 years of age.
- Subject is pregnant.
- Subject is incarcerated at the time of the study.
- Subject, or subject's legally authorized representative is unable or unwilling to provide informed consent.
- Subject is affected by a condition that, in the opinion of the treatment 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 coagulation properties of a whole blood sample at the point-of-care. | Diagnostic test | ECMO Patients |
Primary outcome
Comparison of Quantra Clot Time results to standard coagulation test results.
Time frame: At the start of ECMO (considered the Baseline timepoint)
Coagulation function assessed by Quantra and standard-of-care coagulation tests
Comparison of Quantra Clot Stiffness results to standard coagulation test results.
Time frame: At the start of ECMO (considered the Baseline timepoint)
Coagulation function assessed by Quantra and standard-of-care coagulation tests
Comparison of Quantra Clot Time results to standard coagulation test results.
Time frame: 6 hours after the previous measurment
Coagulation function assessed by Quantra and standard-of-care coagulation tests
Comparison of Quantra Clot Stiffness results to standard coagulation test results.
Time frame: 6 hours after the previous measurment
Coagulation function assessed by Quantra and standard-of-care coagulation tests
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 15 Jun 2023.
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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 Blood Loss and Thrombosis, 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 15 Jun 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 Quantra Clot Time results to standard coagulation test results. (time frame: At the start of ECMO (considered the Baseline timepoint)). The study lists 4 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 15 Jun 2023.