Healthy, Pediatric ALL
Conditions
Keywords
QPlus, Quantra, Pediatric, Reference Range
Brief summary
Evaluation of coagulation results reported by the Qplus Quantra System to determine pediatric reference range intervals.
Detailed description
Single center observational study of the pediatric patient population (\< 18yrs) with normal coagulation function to determine the reference range interval for the clotting parameters reported by the Quantra QPlus system.
Interventions
DEVICEDiagnostic Test
Diagnostic device to monitor coagulation properties of a whole blood sample at the point of care
Sponsors
HemoSonics LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* \<18yrs * Scheduled for procedure requiring anesthesia * Access to blood sampling * Consented
Exclusion criteria
* \>18yrs of age * pre-term babies * patients with know hematological disorders * Difficult to obtain blood sampling * Has received a blood product transfusion within the last 24hrs. * Legal guardian unwilling to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reference range interval for measurement of clot time (CT) parameter | Baseline, after access placement before any procedures | Reference range interval determined in this study will serve as the reference for CT results in this particular population |
| Reference range interval for measurement of clot time (CTH) parameter | Baseline, after access placement before any procedures | Reference range interval determined in this study will serve as the reference for CTH results in this particular population |
| Reference range interval for measurement of clot stiffness (CS) parameter | Baseline, after access placement before any procedures | Reference range interval determined in this study will serve as the reference for CS results in this particular population |
| Reference range interval for measurement of Fibrinogen Contribution to clot stiffness (FCS) parameter | Baseline, after access placement before any procedures | Reference range interval determined in this study will serve as the reference for FCS results in this particular population |
| Reference range interval for measurement of Platelet Contribution to clot stiffness (PCS) parameter | Baseline, after access placement before any procedures | Reference range interval determined in this study will serve as the reference for PCS results in this particular population |
Countries
United States
Outcome results
None listed