Reference Range Study for the Quantra System With the QPlus Cartridge in Pediatric Patients
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 17
SponsorHemoSonics LLC
About this trial
This study will determine reference range intervals for the parameters reported by the Quantra System with the QPlus Cartridge in pediatric patients.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Quantra System
Treatment groups
240 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov