QStat Cartridge in Obstetric Patients

HemoSonics

Status

Completed

Conditions

Blood Loss Massive

Post Partum Hemorrhage

Treatments

Diagnostic Test: Quantra Hemostasis Analyzer with the QStat Cartridge

Study type

Observational

Funder types

Industry

Identifiers

NCT06255496

HEMCS-048

Details and patient eligibility

About

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.

Full 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.

Enrollment

296 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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