Performance Evaluation of Von Willebrand:Collagen-Binding Assays to Diagnose Von Willebrand Factor Deficiency in Patients With Increased Risk of Bleeding (PERICOLL)
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|ClinicalTrials.gov Identifier: NCT02792205|
Recruitment Status : Recruiting
First Posted : June 7, 2016
Last Update Posted : February 1, 2019
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 (VWF:RCo). However, in these patients, the use of alternative methods, such as PFA-100 (Platelet Fonction Analyzer-100), the study of Factor VIII (FVIII:C) to VWF (FVIII:C/VWF) ratio or the evaluation of VWF activity using more specialized methods such as VWF:CB (VWF-Collagen Binding) assay can detect the VWF deficiency and possible hemorrhagic predisposition.
In this project, the investigators plan to assess the performance of VWF:CB in the diagnosis of VWF deficiency in patients with unexplained bleeding history.
|Condition or disease||Intervention/treatment|
|Von Willebrand Disease||Other: Non interventional study|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Performance Evaluation of Von Willebrand:Collagen-Binding Assays to Diagnose Von Willebrand Factor Deficiency in Patients With Increased Risk of Bleeding|
|Actual Study Start Date :||February 22, 2017|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2020|
- Other: Non interventional study
- Von Willebrand factor levels measured with Von Willebrand factor: Collagen-Binding methods [ Time Frame: Up to 1 year ]
Deficiency is defined when VWF level is < 50IU/dL, as usually defined by Favaloro E.J. (2000).
A composite reference standard (CRS) will be used to improve the imperfect Gold Standard (VWF: RCo). CRS will be defined as being positive if either VWF: RCo, VWF:Ag, PFA-100 or FVIII:C will be positive and negative otherwise.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02792205
|Contact: Marc Trossaërt, Dr||02 40 08 74 email@example.com|
|Contact: Valérie Horvais||02 40 08 79 firstname.lastname@example.org|
|Dijon University Hospital||Recruiting|
|Dijon, France, 21079|
|Contact: Emmanuel De Maistre, Dr 03.80.29.33.14 email@example.com|
|Principal Investigator: Emmanuel De Maistre, Dr|
|Nantes University Hospital||Recruiting|
|Nantes, France, 44093|
|Contact: Marc Trossaërt, Dr 02 40 08 74 68 firstname.lastname@example.org|
|Principal Investigator: Marc Trossaërt, Dr|
|Principal Investigator:||Marc Trossaërt, Dr||Nantes University Hospital|