NCT06415760

Reference Range Study for the Quantra System With the QStat Cartridge in Obstetric Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 129 (actual)
• Sponsor: HemoSonics LLC · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study will determine reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge in the last trimester of non-laboring pregnant women with an uncomplicated pregnancy

Detailed description

During pregnancy, there is a progressive shift of hemostasis toward a hypercoagulable state that is protective against postpartum hemorrhage. To assess the clinical utility of the Quantra System in high-risk OB patients during delivery, it is important to understand how the normal physiological changes of pregnancy impact Quantra results. This study will determine reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge in the last trimester of non-laboring pregnant women with an uncomplicated pregnancy.

Conditions

• Obstetric Hemostasis
• 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: 2024-05-07
• Primary completion: 2025-04-01
• Completion: 2025-07-01
• First posted: 2024-05-16
• Last updated: 2025-07-23

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study