Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 12:34 AM
Study NCT ID:
NCT06415760
Status:
COMPLETED
Last Update Posted:
2025-07-23
First Post:
2024-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reference Range Study for the Quantra System With the QStat Cartridge in Obstetric Patients
Sponsor:
HemoSonics LLC
Organization:
Study Overview
Official Title:
Reference Range Study for the Quantra System With the QStat Cartridge in Obstetric Patients
Status:
COMPLETED
Status Verified Date:
2025-07
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 determine reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge in the last trimester of non-laboring pregnant women with an uncomplicated pregnancy
Detailed Description:
During pregnancy, there is a progressive shift of hemostasis toward a hypercoagulable state that is protective against postpartum hemorrhage. To assess the clinical utility of the Quantra System in high-risk OB patients during delivery, it is important to understand how the normal physiological changes of pregnancy impact Quantra results. This study will determine reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge in the last trimester of non-laboring pregnant women with an uncomplicated pregnancy.
Study Oversight
Has Oversight DMC:
False
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?: