Reference Range Study for the Quantra System With the QPlus Cartridge in Pediatric Patients

Reference Range Study for the Quantra System With the QPlus Cartridge in Pediatric Patients

This study will determine reference range intervals for the parameters reported by the Quantra System with the QPlus Cartridge in pediatric patients.

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.

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 ≤3.
• 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%