National Study of Moderate and Severe Von Willebrand Disease in the Netherlands

NCT00510042 | Completed

• 1 other identifier: MEC-2007-063
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 12

Brief Summary

The objective of this study is to assess the clinical presentation, the treatment and the complications of the disease and treatment in moderate and severe von Willebrand disease. Another goal is to investigate the influence of von Willebrand disease on quality of life.

Conditions

Von Willebrand Disease

Keywords

von Willebrand disease; von Willebrand factor; national study; bleeding disorder; quality of life

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with moderate and devere von Willebrand disease, known in a hemophilia treatment center

You may qualify if:

• haemorrhagic symptoms or a family history of von Willebrand disease
• vWF antigen ≤ 30%, lowest measurement counts and/or vWF activity (vWF:RCo of vWF:CB) ≤ 30%, lowest measurement counts and/or FVIII:C ≤ 40 %, lowest measurement counts
• being known in a hemophilia treatment center or if only the diagnose is made in a hemophilia treatment center this must be done after 1987

You may not qualify if:

• Hemophilia A
• Carriership of hemophilia A
• No informed consent

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Foundation Haemophilia: collaborator
• CSL Behring: collaborator

Study Sites (12)

Academic Medical Center Amsterdam

Amsterdam, Netherlands

Location

VU University Medical Center

Amsterdam, Netherlands

Location

Amphia Hospital

Breda, Netherlands

Location

Maxima Medical Center

Eindhoven, Netherlands

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Kennemer Hospital

Haarlem, Netherlands

Location

Leiden University Medical Center

Leiden, Netherlands

Location

Academic Hospital Maastricht

Maastricht, Netherlands

Location

University Medical Center St. Radboud

Nijmegen, Netherlands

Location

Erasmus University Medical Center

Rotterdam, 3000 CA, Netherlands

Location

Haga Hospital

The Hague, Netherlands

Location

University Medical Center Utrecht Van Creveldkliniek

Utrecht, Netherlands

Location

Related Publications (5)

• Mannucci PM. Treatment of von Willebrand's Disease. N Engl J Med. 2004 Aug 12;351(7):683-94. doi: 10.1056/NEJMra040403. No abstract available.

  PMID: 15306670 BACKGROUND

• Sadler JE, Mannucci PM, Berntorp E, Bochkov N, Boulyjenkov V, Ginsburg D, Meyer D, Peake I, Rodeghiero F, Srivastava A. Impact, diagnosis and treatment of von Willebrand disease. Thromb Haemost. 2000 Aug;84(2):160-74. No abstract available.

  PMID: 10959685 BACKGROUND

• Sadler JE. A revised classification of von Willebrand disease. For the Subcommittee on von Willebrand Factor of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Thromb Haemost. 1994 Apr;71(4):520-5.

  PMID: 8052974 BACKGROUND

• Tosetto A, Rodeghiero F, Castaman G, Goodeve A, Federici AB, Batlle J, Meyer D, Fressinaud E, Mazurier C, Goudemand J, Eikenboom J, Schneppenheim R, Budde U, Ingerslev J, Vorlova Z, Habart D, Holmberg L, Lethagen S, Pasi J, Hill F, Peake I. A quantitative analysis of bleeding symptoms in type 1 von Willebrand disease: results from a multicenter European study (MCMDM-1 VWD). J Thromb Haemost. 2006 Apr;4(4):766-73. doi: 10.1111/j.1538-7836.2006.01847.x.

  PMID: 16634745 BACKGROUND

• Federici AB. Clinical diagnosis of von Willebrand disease. Haemophilia. 2004 Oct;10 Suppl 4:169-76. doi: 10.1111/j.1365-2516.2004.00991.x.

  PMID: 15479393 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

plasma, DNA

MeSH Terms

Conditions

von Willebrand Diseases; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Blood Platelet Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Eva M de Wee, MD

  Erasmus Medical Center

  STUDY DIRECTOR

• Frank WG Leebeek, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

• Karin Fijn van Draat, MD, PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  STUDY CHAIR

• Jeroen CJ Eikenboom, MD, PhD

  Leiden University Medical Center

  STUDY CHAIR

• Arja de Goede-Bolder, MD

  Erasmus Medical Center

  STUDY CHAIR

• Eveline P Mauser-Bunschoten, MD, PhD

  Van Creveldkliniek, University Medical Center Utrecht

  STUDY CHAIR

• Karina Meijer, MD, PhD

  University Medical Center Goningen

  STUDY CHAIR

• Britta Laros-van Gorkom, MD, PhD

  University Medical Center St. Radboud Nijmegen

  STUDY CHAIR

• Johanna G van der Bom, PhD

  Leiden University Medical Center

  STUDY CHAIR

• Manon A Degenaar-Dujardin, BA

  Organization for Hemophilia Patients

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 31, 2007
• First Posted: August 1, 2007
• Study Start: July 1, 2007
• Study Completion: September 1, 2009
• Last Updated: April 26, 2010

Record last verified: 2010-04

Locations

NL (12)