Ignite Creation Date:
2024-05-06 @ 8:40 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02792205
Status:
COMPLETED
Last Update Posted:
2022-06-10
First Post:
2016-06-02
Brief Title:
Performance Evaluation of Von WillebrandCollagen-Binding Assays to Diagnose Von Willebrand Factor Deficiency in Patients With Increased Risk of Bleeding
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Performance Evaluation of Von WillebrandCollagen-Binding Assays to Diagnose Von Willebrand Factor Deficiency in Patients With Increased Risk of Bleeding
Status:
COMPLETED
Status Verified Date:
2022-06
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:
PERICOLL
Brief Summary:
Von Willebrand Disease VWD is defined as an inherited bleeding disorder that is caused by deficiency or dysfunction of von Willebrand factor VWF a plasma protein that mediates the initial adhesion of platelets at sites of vascular injury and also binds and stabilizes blood clotting factor VIII FVIII in the circulation The most severe forms of VWD are usually easy to diagnose obvious hemorrhagic symptoms and major VWF deficiency whereas the mild forms of the disease are still difficult to confirm It is indeed reported that about 1 of the population carry mild biological VWF deficiency without any bleeding tendency and any actual disease On the contrary some patients with severe bleeding history can carry a true VWF abnormality well-confirmed by genetic studies without any VWF deficiency when evaluated with standard biological methods such as Ristocetin Cofactor activity VWFRCo However in these patients the use of alternative methods such as PFA-100 Platelet Fonction Analyzer-100 the study of Factor VIII FVIIIC to VWF FVIIICVWF ratio or the evaluation of VWF activity using more specialized methods such as VWFCB VWF-Collagen Binding assay can detect the VWF deficiency and possible hemorrhagic predisposition
In this project the investigators plan to assess the performance of VWFCB in the diagnosis of VWF deficiency in patients with unexplained bleeding history
In this project the investigators plan to assess the performance of VWFCB in the diagnosis of VWF deficiency in patients with unexplained bleeding history
Detailed Description:
None
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