Reference Range Study for the Quantra System With the QPlus Cartridge in Pediatric Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- HemoSonics LLC
- Enrollment
- 240
- Locations
- 4
- Primary Endpoint
- Reference range intervals for measurement of Clot Time (CT) parameter
Study Overview
Brief Summary
This study will determine reference range intervals for the parameters reported by the Quantra System with the QPlus Cartridge in pediatric patients.
Detailed Description
The hemostatic profile of an infant is different than that of an adult and changes with age. Most differences occur within the first 6 months of age, with coagulation function similar to that of an adult within the first year of life. To assess the clinical utility of the Quantra System in pediatric patients that are bleeding or at risk for bleeding, it is important to understand the normal reference intervals for the parameters reported by the QPlus Cartridge in normal, healthy pediatric patients.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject is <18 years of age
- •Corrected gestational age ≥ 37weeks
- •Subject is scheduled for an elective surgery, non-surgical intervention or diagnostic procedure requiring anesthesia and vascular access with an ASA score ≤
- •Subject's parent or guardian has signed an informed consent form. If required, subject has signed an assent form.
Exclusion Criteria
- •Subject is hospitalized in the Pediatric Intensive Care Unit
- •Subject requires Extracorporeal Membrane Oxygenation (ECMO)
- •Subject has had an infection within 7 days of the scheduled procedure
- •Subject has an active coagulation disorder (bleeding or thrombosis)
- •For subjects that have a hemoglobin measurement within 24 hours of the scheduled procedure, hemoglobin is <8g/dL or >16g/dL
- •Subject has a baseline oxygen saturation <92%
Arms & Interventions
Pediatric patients
Intervention: Quantra System (Diagnostic Test)
Outcomes
Primary Outcomes
Reference range intervals for measurement of Clot Time (CT) parameter
Time Frame: Baseline, determined from a single blood draw
Reference range intervals for CT in pediatric patients
Reference range intervals for measurement of Clot Time with Heparinase (CTH) parameter
Time Frame: Baseline, determined from a single blood draw.
Reference range intervals for CTH in pediatric patients
Reference range intervals for measurement of Clot Stiffness (CS) parameter
Time Frame: Baseline, determined from a single blood draw
Reference range intervals for CS in pediatric patients
Reference range intervals for measurement of Fibrinogen Contribution (FCS) parameter
Time Frame: Baseline, determined from a single blood draw
Reference range intervals for FCS in pediatric patients
Reference range intervals for measurement of Platelet Contribution (PCS) parameter
Time Frame: Baseline, determined from a single blood draw
Reference range intervals for PCS in pediatric patients
Secondary Outcomes
No secondary outcomes reported