Ignite Creation Date:
2024-05-06 @ 7:05 AM
Last Modification Date:
2024-10-26 @ 11:44 AM
Study NCT ID:
NCT02466789
Status:
COMPLETED
Last Update Posted:
2022-08-10
First Post:
2015-06-05
Brief Title:
Investigating a Von Willebrand Factor VWF Functional Screening Assay for Assigning the Phenotypic Variants of Von Willebrand Disease VWD
Sponsor:
Jonathan Roberts
Organization:
Bleeding and Clotting Disorders Institute Peoria Illinois
Study Overview
Official Title:
Investigating a Von Willebrand Factor VWF Functional Screening Assay for Assigning the Phenotypic Variants of Von Willebrand Disease VWD
Status:
COMPLETED
Status Verified Date:
2022-08
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:
VWF-phV
Brief Summary:
The purpose of this study is to improve the investigators ability to diagnose von Willebrand Disease VWD a common inherited bleeding disorder This study will look at a new screening blood test used to determine if a person has VWD This new screening blood test can determine a diagnosis more rapidly than current blood tests Also this test could be available at local hospital labs rather than require samples to be sent to bigger more specialized labs
Detailed Description:
This investigation will be a prospective multicenter trial to validate the clinical utility of a novel screening assay as a diagnostic screening assay for VWD variants Type 1C 2A 2B 2M and 2N Once the subject is enrolled into the study a minimum of 05ml of citrated plasma will be collected and analyzed at the Bleeding and Clotting Disorders Institute Laboratory in Peoria Illinois Results will be collected phenotype function profiles will be determined statistically analyzed and compared to the qualitative data from Blood Center of Wisconsin Data is expected to correlate as previously shown in prior studies and will confirm the utility of this assay
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None