Coagulation, Pediatric
Conditions
Keywords
Reference range, Quantra QPlus
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.
Interventions
DIAGNOSTIC_TESTQuantra System
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
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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reference range intervals for measurement of Clot Time (CT) parameter | 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 | 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 | 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 | 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 | Baseline, determined from a single blood draw | Reference range intervals for PCS in pediatric patients |
Countries
Switzerland, United States
Contacts
CONTACTDeborah Winegar, PhD
Outcome results
None listed