HemorrhageNCT04312958
Quantra QStat in Trauma and Liver Transplant
An observational study of Hemorrhage and Trauma, run by HemoSonics LLC at 10 sites in United States.
Trial summary
This is a multi-center prospective, observational study of the Quantra System with the QStat Cartridge in trauma patients and patients undergoing liver transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhage, Trauma, Liver Transplant
- What is being tested?
- Quantra System
- How many people
- 397 participants
- Where
- 10 sitesUnited States
- Study dates
- 20 Jul 2020to 13 Apr 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
- Adult, Older adult
Study population: Potential study participants will be adult (>18 years) trauma patients or patients undergoing liver transplant surgery.
Who may be able to join
- Subject is > 18 years
- Subject is a trauma patient experiencing traumatic injuries requiring a full trauma team response OR Subject is a patient undergoing liver transplant surgery.
- Subject, or subject's legally authorized representative (LAR), is willing to provide informed consent, either prospectively or by deferred consent, OR Institutional Review Board (IRB)/Ethics Committee (EC) has waived the requirement to obtain informed 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 is currently enrolled in a distinct study that might confound the result of the proposed study
- Subject is affected by a condition that, in the opinion of the surgical team, may pose additional risks.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 98109
University of Virginia Medical Center
Charlottesville, Virginia, 22903
Ohio State University
Columbus, Ohio, 43210
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
University of Colorado
Denver, Colorado, 28037
Texas Tech University Health Sciences Center
El Paso, Texas, 79905
University of Florida Health Shands Hospital
Gainesville, Florida, 32608
University of Oklahoma Medical Center
Oklahoma City, Oklahoma, 73104
Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, 94110
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303
About this study
Official title: Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in Trauma and Liver Transplantation
This is a multi-center prospective, observational study of the Quantra System with the QStat Cartridge in trauma patients and patients undergoing liver transplant.
Read the detailed description
The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The QStat Cartridge was developed to monitor hemostasis in patients that may experience a range of coagulopathies of various etiologies, including fibrinolytic defects. These patients include the trauma and liver transplant populations. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding five parameters that depict the functional status of a patient's coagulation system.
This multi-center, prospective, observational pilot study will evaluate the performance of the Quantra System with the QStat Cartridge as compared to conventional viscoelastic testing methods in blood samples obtained from trauma patients and patients undergoing liver transplant.
- Conditions
- Hemorrhage, Trauma, Liver Transplant
- Being tested
- Quantra System
- Keywords
- Viscoelastic testing, Coagulation, Trauma, Liver Transplant, Quantra, QStat
- Medical subject headings
- Hemorrhage, Wounds and Injuries, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantra SystemDiagnostic test
Also called Quantra QStat Cartridge
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
| Study group | Role | What they receive |
|---|---|---|
| Trauma patients | Trauma patients experiencing traumatic injuries requiring a full trauma team response. Receives: Diagnostic Test: Quantra System | |
| Liver transplant patients | Patients undergoing liver transplant surgery. 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 (CT) to ROTEM Delta INTEM CT results
Coagulation function assessed by Quantra and ROTEM Delta
Measured: Upon arrival of trauma subject to the emergency department
Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results
Coagulation function assessed by Quantra and ROTEM Delta
Measured: Baseline, immediately before the start of liver transplant surgery
Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results
Coagulation function assessed by Quantra and ROTEM Delta
Measured: During anhepatic phase of liver transplant surgery
Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results
Coagulation function assessed by Quantra and ROTEM Delta
Measured: During post-reperfusion phase of liver transplant surgery
Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results
Coagulation function assessed by Quantra and ROTEM Delta
Measured: Upon arrival of trauma subject to the emergency department
Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results
Coagulation function assessed by Quantra and ROTEM Delta
Measured: Baseline, immediately before the start of liver transplant surgery
Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results
Coagulation function assessed by Quantra and ROTEM Delta
Measured: During anhepatic phase of liver transplant surgery
Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results
Coagulation function assessed by Quantra and ROTEM Delta
Measured: During post-reperfusion phase of liver transplant surgery
Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results
Coagulation function assessed by Quantra and ROTEM Delta
Measured: Upon arrival of trauma subject to the emergency department
Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results
Coagulation function assessed by Quantra and ROTEM Delta
Measured: Baseline, immediately before the start of liver transplant surgery
Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results
Coagulation function assessed by Quantra and ROTEM Delta
Measured: During anhepatic phase of liver transplant surgery
Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results
Coagulation function assessed by Quantra and ROTEM Delta
Measured: During post-reperfusion phase of liver transplant surgery
Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results
Coagulation function assessed by Quantra and ROTEM Delta
Measured: Upon arrival of trauma subject to the emergency department
Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results
Coagulation function assessed by Quantra and ROTEM Delta
Measured: Baseline, immediately before the start of liver transplant surgery
Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results
Coagulation function assessed by Quantra and ROTEM Delta
Measured: During anhepatic phase of liver transplant surgery
Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results
Coagulation function assessed by Quantra and ROTEM Delta
Measured: During post-reperfusion phase of liver transplant surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start20 Jul 2020
- Primary completion31 Dec 2022
- Study completion13 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemorrhageStudies 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
- 397 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
- NCT04312958
- Sponsor's protocol ID
- HEMCS-032
- Status last verified
- Apr 2023
- First submitted
- 15 Mar 2020
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Moore EE, Michelson EA, Gabriel-Ramos K, Cripps MW, Flores A, Vandyck K, Thurston B, Brennan M, Viola F, Winegar DA. Multicenter evaluation of the Quantra with the QStat Cartridge in adult trauma patients. Trauma Surg Acute Care Open. 2025 Jun 3;10(2):e001672. doi: 10.1136/tsaco-2024-001672. eCollection 2025.
PubMed 40486089
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. 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 QStat Cartridge in Trauma and Liver Transplantation
- ClinicalTrials.gov ID
- NCT04312958
- Acronym / sponsor ID
- HEMCS-032
- Conditions
- Hemorrhage, Trauma, Liver Transplant
- Keywords
- Viscoelastic testing, Coagulation, Trauma, Liver Transplant, Quantra, QStat
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- HemoSonics LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 13 Apr 2023 (actual)
- First posted
- 18 Mar 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.
This is a multi-center prospective, observational study of the Quantra System with the QStat Cartridge in trauma patients and patients undergoing liver transplant.
Detailed description
The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The QStat Cartridge was developed to monitor hemostasis in patients that may experience a range of coagulopathies of various etiologies, including fibrinolytic defects. These patients include the trauma and liver transplant populations. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding five parameters that depict the functional status of a patient's coagulation system.
This multi-center, prospective, observational pilot study will evaluate the performance of the Quantra System with the QStat Cartridge as compared to conventional viscoelastic testing methods in blood samples obtained from trauma patients and patients undergoing liver transplant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trauma patients | – | Diagnostic Test: Quantra SystemTrauma patients experiencing traumatic injuries requiring a full trauma team response. |
| Liver transplant patients | – | Diagnostic Test: Quantra SystemPatients undergoing liver transplant surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Potential study participants will be adult (>18 years) trauma patients or patients undergoing liver transplant surgery.
Key inclusion criteria (3 listed)
- Subject is > 18 years
- Subject is a trauma patient experiencing traumatic injuries requiring a full trauma team response OR Subject is a patient undergoing liver transplant surgery.
- Subject, or subject's legally authorized representative (LAR), is willing to provide informed consent, either prospectively or by deferred consent, OR Institutional Review Board (IRB)/Ethics Committee (EC) has waived the requirement to obtain informed 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 is currently enrolled in a distinct study that might confound the result of the proposed study
- Subject is affected by a condition that, in the opinion of the surgical 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 SystemAlso: Quantra QStat CartridgeDiagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care. | Diagnostic test | Liver transplant patients, Trauma patients |
Primary outcome
Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results
Time frame: Upon arrival of trauma subject to the emergency department
Coagulation function assessed by Quantra and ROTEM Delta
Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results
Time frame: Baseline, immediately before the start of liver transplant surgery
Coagulation function assessed by Quantra and ROTEM Delta
Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results
Time frame: During anhepatic phase of liver transplant surgery
Coagulation function assessed by Quantra and ROTEM Delta
Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results
Time frame: During post-reperfusion phase of liver transplant surgery
Coagulation function assessed by Quantra and ROTEM Delta
Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results
Time frame: Upon arrival of trauma subject to the emergency department
Coagulation function assessed by Quantra and ROTEM Delta
Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results
Time frame: Baseline, immediately before the start of liver transplant surgery
Coagulation function assessed by Quantra and ROTEM Delta
Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results
Time frame: During anhepatic phase of liver transplant surgery
Coagulation function assessed by Quantra and ROTEM Delta
Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results
Time frame: During post-reperfusion phase of liver transplant surgery
Coagulation function assessed by Quantra and ROTEM Delta
Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results
Time frame: Upon arrival of trauma subject to the emergency department
Coagulation function assessed by Quantra and ROTEM Delta
Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results
Time frame: Baseline, immediately before the start of liver transplant surgery
Coagulation function assessed by Quantra and ROTEM Delta
Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results
Time frame: During anhepatic phase of liver transplant surgery
Coagulation function assessed by Quantra and ROTEM Delta
Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results
Time frame: During post-reperfusion phase of liver transplant surgery
Coagulation function assessed by Quantra and ROTEM Delta
Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results
Time frame: Upon arrival of trauma subject to the emergency department
Coagulation function assessed by Quantra and ROTEM Delta
Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results
Time frame: Baseline, immediately before the start of liver transplant surgery
Coagulation function assessed by Quantra and ROTEM Delta
Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results
Time frame: During anhepatic phase of liver transplant surgery
Coagulation function assessed by Quantra and ROTEM Delta
Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results
Time frame: During post-reperfusion phase of liver transplant surgery
Coagulation function assessed by Quantra and ROTEM Delta
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 3 May 2023.
- Derived from this study: PubMed 40486089Moore EE, Michelson EA, Gabriel-Ramos K, Cripps MW, Flores A, Vandyck K, Thurston B, Brennan M, Viola F, Winegar DA. Multicenter evaluation of the Quantra with the QStat Cartridge in adult trauma patients. Trauma Surg Acute Care Open. 2025 Jun 3;10(2):e001672. doi: 10.1136/tsaco-2024-001672. eCollection 2025.
- 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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhage and Trauma, run by HemoSonics LLC at 10 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 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 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
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 (CT) to ROTEM Delta INTEM CT results (time frame: Upon arrival of trauma subject to the emergency department). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04312958, which also lists 1 linked publication.
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 3 May 2023.