Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06255496
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-13
First Post:
2024-02-04
Brief Title:
QStat Cartridge in Obstetric Patients
Sponsor:
HemoSonics LLC
Organization:
HemoSonics LLC
Study Overview
Official Title:
Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in Obstetric Patients
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None