- Solid Tumors
- Pipeline Molecules
- Alliance Partners
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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03934983
Recruitment Status Completed
First Posted May 2, 2019
Last update posted February 13, 2020
This pilot study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QStat Cartridge in trauma patients.
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 patient population. 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 single-center, prospective, observational pilot study will evaluate the performance of the Quantra System with the QStat Cartridge as compared to standard coagulation tests and comparable measures using conventional viscoelastic testing methods.
|: Trauma patients
Subject experiencing major trauma such that viscoelastic testing is performed as standard of care to assess coagulopathy.
Diagnostic Test: Quantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- Subject is ≥ 18 years of age
- Subject is a trauma patient and is a candidate for a ROTEM test to be performed to
- Subject must be 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.
- Subject is willing to participate, and is willing to consent (either prospectively or
by deferred consent)
- Subject is younger than 18 years of age
- Subject weighs less than 110 pounds
- Subject is known to have received antifibrinolytic therapy immediately prior to
presentation to trauma unit
- Subject is unable to provide written informed consent (either prior to performing any
study related procedures or by deferred consent)
- 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
United States, Texas
University of Texas Southwestern Medical Center