An observational study in Blood Loss Massive and Trauma, sponsored by HemoSonics LLC. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-13.
Sponsored by HemoSonics LLC · Observational
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.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's enrollment of 30 is below the median of 135 across 1,597 observational studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →HemoSonics LLC is the lead sponsor of 25 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Potential study participants will be adult (>18 years) trauma patients where visicoelastic testing is performed as standard of care to assess coagulopathy.
Exclusion Criteria:
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.
Also known as: Quantra QStat Cartridge
Comparison of the Quantra Clot Time results to standard coagulation test results
Coagulation function assessed by Quantra and standard coagulation tests
Time frame: Upon arrival to emergency department
Comparison of the Quantra Clot Stiffness results to standard coagulation test results
Coagulation function assessed by Quantra and standard coagulation tests
Time frame: Upon arrival to emergency department
Comparison of the Quantra Clot Time results to ROTEM Delta results
Coagulation function assessed by Quantra and ROTEM delta
Time frame: Upon arrival to emergency department
Comparison of the Quantra Clot Stiffness results to ROTEM Delta results
Coagulation function assessed by Quantra and ROTEM delta
Time frame: Upon arrival to emergency department
Comparison of the Quantra Fibrinolysis results to ROTEM Delta results
Coagulation function assessed by Quantra and ROTEM delta
Time frame: Upon arrival to emergency department
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
HemoSonics LLC