NCT06255496

QStat Cartridge in Obstetric Patients

Evaluation of the Clinical Performance of the Quantra® System With the QStat® Cartridge in Obstetric Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 296 (actual)
• Sponsor: HemoSonics LLC · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the performance of the Quantra System with the QStat Cartridge versus standard of care coagulation testing in pregnant women at risk of bleeding at delivery.

Detailed description

The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The QStat Cartridge was developed to monitor hemostasis in patients that may experience a range of coagulopathies of various etiologies including fibrinolytic defects. These patients include the tobstetric hemorrhage population. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding five parameters that depict the functional status of a patient's coagulation system. This multicenter, prospective, observational pilot study will evaluate the performance of the Quantra System with the QStat Cartridge as compared to standard of care coagulation testing in pregnant women at risk of bleeding at delivery.

Conditions

• Blood Loss Massive
• Post Partum Hemorrhage

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Quantra Hemostasis Analyzer with the QStat Cartridge	Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Timeline

• Start date: 2024-05-09
• Primary completion: 2025-08-15
• Completion: 2025-10-30
• First posted: 2024-02-13
• Last updated: 2025-11-14

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study