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

Starting soon

Conditions studied: Pediatric, Coagulation

In brief

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

Key facts

Study ID

NCT07447713

Run by

HemoSonics LLC

People needed

240

Starts

2026-04-15

Expected to finish

2027-05-30

Last updated by the study team

2026-03-03

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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%

Where it is running

• UCLA Mattel Children's Hospital — Los Angeles, California, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• University Children's Hospital Zurich — Zurich, Switzerland

Full record on ClinicalTrials.gov

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