NCT07447713

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 240 (estimated)
• Sponsor: HemoSonics LLC · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: —

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.

Conditions

• Pediatric
• Coagulation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Quantra System	Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Timeline

• Start date: 2026-04-15
• Primary completion: 2027-04-30
• Completion: 2027-05-30
• First posted: 2026-03-03
• Last updated: 2026-03-03

Locations

4 sites across 2 countries: United States, Switzerland

Regulatory

• FDA-regulated device study