QStat Pilot Reference Range Study
- Conditions
- Coagulation Disorder
- Interventions
- Diagnostic Test: Quantra System
- Registration Number
- NCT04490759
- Lead Sponsor
- HemoSonics LLC
- Brief Summary
The objective is to determine the initial reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge.
- Detailed Description
This is a single center prospective, observational study of a healthy adult population with normal coagulation function to determine the initial reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge. The threshold for the Clot Stability to Lysis (CSL) parameter will be determined from the CSL reference range.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Subject is 18 years or older
- Subject is willing to participate and has signed a consent form
- Subject's laboratory coagulation test results at screening are within each test's normal reference range.
- Subject is younger than 18 years
- Subject has a history of a coagulation disorder
- Subject is pregnant or lactating
- Subject is currently taking medications known to alter coagulation
- Subject has one or more laboratory coagulation test restuls outside of the normal reference range at screening
- Subject had a blood transfusion or surgery within the last month
- Drug abuse
- Excessive alcohol consumption
- Subject is unable to provide written informed consent
- Subject is incarcerated at the time of the study
- Subject previously participated in this study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Healthy volunteers Quantra System Blood samples from healthy volunteers analyzed on the Quantra System
- Primary Outcome Measures
Name Time Method Reference range intervals for measurement of Clot Stiffness (CS) parameter Baseline, determined from a single blood draw Reference range intervals determined in this study will serve as the reference range for CS on the QStat Cartridge when it is commercially available.
Reference range intervals for measurement of Platelet Contribution to Clot Stiffness (PCS) parameter Baseline, determined from a single blood draw Reference range intervals determined in this study will serve as the reference range for PCS on the QStat Cartridge when it is commercially available.
Reference range intervals for measurement of Clot Time (CT) parameter Baseline, determined from a single blood draw Reference range intervals determined in this study will serve as the reference range for CT on the QStat Cartridge when it is commercially available.
Reference range intervals for measurement of Fibrinogen Contribution to Clot Stiffness (FCS) parameter Baseline, determined from a single blood draw Reference range intervals determined in this study will serve as the reference range for FCS on the QStat Cartridge when it is commercially available.
Reference range intervals for measurement of Clot Stability to Lysis (CSL) parameter Baseline, determined from a single blood draw Reference range intervals determined in this study will serve as the reference range for CSL on the QStat Cartridge when it is commercially available.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
M3 Wake Research
🇺🇸Raleigh, North Carolina, United States