QStat Cartridge in Obstetric Patients

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06255496
Study type	Observational
Source	HemoSonics LLC
Contact	Deborah A Winegar
Phone	9192446990
Email	dwinegar@hemosonics.com
Status	Not yet recruiting
Phase
Start date	March 1, 2024
Completion date	December 31, 2024

View Details

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