Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510042
Status:
COMPLETED
Last Update Posted:
2010-04-26
First Post:
2007-07-31
Brief Title:
National Study of Moderate and Severe Von Willebrand Disease in the Netherlands
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
National Study of Moderate and Severe Von Willebrand Disease in the Netherlands
Status:
COMPLETED
Status Verified Date:
2010-04
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:
WiN
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
Detailed Description:
The incidence of von Willebrand disease in the Netherlands is unknown but the occurrence of all types of von Willebrand disease together is estimated at 1100-1200 individuals Most patients have mild von Willebrand disease mostly type 1 For the more severe forms of von Willebrand disease the incidence in unclear but the expectation is that there are at least 500-1500 patients In the Netherlands an unique situation exists for the treatment of patients with hemophilia and related coagulation disorders In 2000 a hemophilia management policy was set up by the Ministry of Health which stated that the care for these patients should be concentrated in 13 Hemophilia Treatment Centers HTC The representatives of the attending centers the hemophilia specialists are organized in the NVHB the Dutch society of Hemophilia treaters In the hemophilia management policy is stated that all patients with a coagulation disorder dependent of replacement products must be treated in a HTC or under responsibility of a HTC These patients are seen in a HTC at least once a year
Because all moderate and severe von Willebrand patients in the Netherlands are known in HTC it is possible to register and study this population This is imperative to the research of von Willebrand disease Because the moderate and severe forms of von Willebrand disease are rare it is impossible for an individual center to perform research of moderate severe and severe von Willebrand disease Therefore a national approach is necessary
For optimal care of patients with the moderate and severe form of von Willebrand disease a better understanding of symptoms diagnostics treatment and complications of treatment is necessary The present study aims to register and investigate all patients in the Netherlands with moderate and severe von Willebrand disease to gain understanding of the clinical presentation the treatment and the complications of treatment in moderate and severe von Willebrand disease Another goal is to investigate the influence of von Willebrand disease on quality of life
To answer these questions a questionnaire is developed which will be sent to the study population In addition blood will be drawn for von Willebrand factor measurement and plasma and DNA will be stored The relationship between laboratory parameters including von Willebrand factor FVIII and prothrombotic coagulation disorders and the clinical phenotype in patients with moderate and severe von Willebrand disease will be studied We will assess the effect of the laboratory parameters on both the severity of bleeding tendency and the possible protecting effect on the risk of arterial thrombosis In the future mutation analysis of the VWF gene will be performed in patients with moderate and severe von Willebrand disease in the Netherlands
Because all moderate and severe von Willebrand patients in the Netherlands are known in HTC it is possible to register and study this population This is imperative to the research of von Willebrand disease Because the moderate and severe forms of von Willebrand disease are rare it is impossible for an individual center to perform research of moderate severe and severe von Willebrand disease Therefore a national approach is necessary
For optimal care of patients with the moderate and severe form of von Willebrand disease a better understanding of symptoms diagnostics treatment and complications of treatment is necessary The present study aims to register and investigate all patients in the Netherlands with moderate and severe von Willebrand disease to gain understanding of the clinical presentation the treatment and the complications of treatment in moderate and severe von Willebrand disease Another goal is to investigate the influence of von Willebrand disease on quality of life
To answer these questions a questionnaire is developed which will be sent to the study population In addition blood will be drawn for von Willebrand factor measurement and plasma and DNA will be stored The relationship between laboratory parameters including von Willebrand factor FVIII and prothrombotic coagulation disorders and the clinical phenotype in patients with moderate and severe von Willebrand disease will be studied We will assess the effect of the laboratory parameters on both the severity of bleeding tendency and the possible protecting effect on the risk of arterial thrombosis In the future mutation analysis of the VWF gene will be performed in patients with moderate and severe von Willebrand disease in the Netherlands
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