QStat Cartridge in Obstetric Patients

Launched by HEMOSONICS LLC · Feb 4, 2024

Keywords

ClinConnect Summary

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 perform...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Subject is greater than18 years.
• • Subject is pregnant or at least 24 h postpartum
• • Conventional coagulation tests and/or viscoelastic testing are ordered for concern of possible coagulopathy based on one or more clinical scenarios including hemorrhage, suspected or confirmed placental abruption, amniotic fluid embolism, or placenta accreta spectrum
• • Subject or subject's LAR is willing to provide informed consent, either prospectively or by deferred consent.
• Exclusion Criteria:
• • Subject is younger than 18 years old.
• • Subject or subject's LAR is unwilling or unable to provide informed consent, either prospectively or by deferred consent.
• • Subject is incarcerated at the time of the study.
• • Subject is currently enrolled in a distinct study that might confound the results of the proposed study
• • Subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks