- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04385953
QStat in Trauma and Obstetric Hemorrhage
Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in Trauma and Obstetric Hemorrhage
Study Overview
Status
Conditions
Intervention / Treatment
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. This includes the trauma, obstetric hemorrhage 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 prospective, observational pilot study will evaluate the performance of the Quantra System with the QStat Cartridge as compared to comparable measures using conventional viscoelastic testing methods.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 941109
- Zuckerberg San Francisco General Hospital and Trauma Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subject is ≥ 18 years of age
- Subject is a trauma patient experiencing major trauma (preferably requiring the highest level of team activation) with active bleeding or deemed at high risk of significant bleeding according to mechanism of injury.and is a candidate for a ROTEM test to be performed to access coagulopathy.
OR
-Subject is an obstetric patient experiencing post-partum hemorrhage based on one of the following conditions: estimated blood loss during delivery >1000 mL; placental abruption with hemorrhage of any quantity; clinically suspected DIC; pregnancy resulted in fetal demise with hemorrhage of any quantity; or is under consideration for administration of tranexamic acid for treatment of hemorrhage.
Exclusion Criteria:
- Subject is younger than 18 years of age
- Subject presents for a procedure intended to abort a pregnancy for reasons other than medical necessity
- Subject is known to have received antifibrinolytic therapy immediately prior to presentation to trauma unit
- Subject is currently enrolled in a distinct study that might confound the results of the proposed study
- Subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Trauma patients
Subject experiencing major trauma
|
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care
Other Names:
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Obstetric patients
Obstetric patient with postpartum hemorrhage
|
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of the Quantra results to corresponding ROTEM Delta results
Time Frame: Upon arrival to emergency department
|
Coagulation function assessed by Quantra and ROTEM delta
|
Upon arrival to emergency department
|
Comparison of the Quantra results to corresponding ROTEM Delta results
Time Frame: At the time of hemorrhage for obstetric patients
|
Coagulation function assessed by Quantra and ROTEM delta
|
At the time of hemorrhage for obstetric patients
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HEMCS-030
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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