Evaluation of a Pediatric Reference Interval Using QPLUS System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pediatric ALL
- Sponsor
- HemoSonics LLC
- Enrollment
- 93
- Locations
- 1
- Primary Endpoint
- Reference range interval for measurement of clot time (CT) parameter
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
Reference range interval for measurement of clot time (CT) parameter
Time Frame: 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 stiffness (CS) parameter
Time Frame: 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 Platelet Contribution to clot stiffness (PCS) parameter
Time Frame: 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
Reference range interval for measurement of clot time (CTH) parameter
Time Frame: 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 Fibrinogen Contribution to clot stiffness (FCS) parameter
Time Frame: 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