Reference Range Study for the Quantra System With the QPlus Cartridge in Pediatric Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Quantra System.
- Who it may be relevant to
- Registry conditions: Pediatric, Coagulation. Basic parameters: up to 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 test Quantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
Primary outcome measures
- Reference range intervals for measurement of Clot Time (CT) parameter [Time frame: Baseline, determined from a single blood draw]
- 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 measurement of Clot Stiffness (CS) parameter [Time frame: Baseline, determined from a single blood draw]
- Reference range intervals for measurement of Fibrinogen Contribution (FCS) parameter [Time frame: Baseline, determined from a single blood draw]
- Reference range intervals for measurement of Platelet Contribution (PCS) parameter [Time frame: Baseline, determined from a single blood draw]
Eligibility criteria
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%
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 3 centers
- UCLA Mattel Children's Hospital — Los Angeles
- Children's Healthcare of Atlanta — Atlanta
- Boston Children's Hospital — Boston
Switzerland · 1 center
- University Children's Hospital Zurich — Zurich
Identifiers
NCT: NCT07447713 · HEMCS-050