Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-30 @ 6:54 AM
Study NCT ID:
NCT05645133
Status:
TERMINATED
Last Update Posted:
2023-06-15
First Post:
2022-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
QPlus Pediatric Reference Interval
Sponsor:
HemoSonics LLC
Organization:
Study Overview
Official Title:
Evaluation of a Pediatric Reference Interval Using QPLUS System
Status:
TERMINATED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI relocated to another institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluation of coagulation results reported by the Qplus Quantra System to determine pediatric reference range intervals.
Detailed Description:
Single center observational study of the pediatric patient population (\< 18yrs) with normal coagulation function to determine the reference range interval for the clotting parameters reported by the Quantra QPlus system.
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?: