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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
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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 (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
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen


Intervention Details:
  • Other: Non interventional study
    no intervention


Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study plans to enroll 200 patients (100 per Center) in a 2-year period. The recruitment will occur in standard consultation activity of the 2 Hemostasis Centers of Dijon and Nantes. As each Center carries out about 1200 consultations/year, this projection appears as feasible, since a majority of them are induced by hemorrhagic profile. Such a number of patients will allow reliable statistical analysis.
Criteria

Inclusion Criteria:

  • Patient with bleeding history sent to the Hemophilia Treatment Center in Dijon or Nantes University Hospital with abnormal bleeding score (>3 in men and >5 in women
  • Patient who has provided a signed consent to participate at this study and for blood sampling
  • Affiliation with French social security system

Non-Inclusion Criteria:

  • Minors will not be included in the study.
  • On-going pregnancy and postpartum period (3 months after delivery)
  • Substitutive treatment with coagulation factor concentrates or desmopressin administration within 10 days before sampling.
  • Ongoing infectious or inflammatory disease that can modify VWF levels.
  • Diagnosis of obvious hemostasis disorder

Information from the National Library of Medicine

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


Contacts
Contact: Marc Trossaërt, Dr 02 40 08 74 68 marc.trossaert@chu-nantes.fr
Contact: Valérie Horvais 02 40 08 79 14 valerie.horvais@chu-nantes.fr

Locations
France
Dijon University Hospital Recruiting
Dijon, France, 21079
Contact: Emmanuel De Maistre, Dr    03.80.29.33.14    emmanuel.demaistre@chu-dijon.fr   
Principal Investigator: Emmanuel De Maistre, Dr         
Nantes University Hospital Recruiting
Nantes, France, 44093
Contact: Marc Trossaërt, Dr    02 40 08 74 68    marc.trossaert@chu-nantes.fr   
Principal Investigator: Marc Trossaërt, Dr         
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Marc Trossaërt, Dr Nantes University Hospital

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02792205     History of Changes
Other Study ID Numbers: RC16_0028
First Posted: June 7, 2016    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Nantes University Hospital:
Willebrand factor deficiency
hematology
Willebrand:Collagen-binding

Additional relevant MeSH terms:
Von Willebrand Diseases
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Blood Platelet Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn