NCT03521583

Brief Summary

The primary aim of this study is to prospectively investigate the current bleeding tendency of children and adults with VWD.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Typical duration for all trials

Geographic Reach
1 country

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
1.2 years until next milestone

Study Start

First participant enrolled

July 28, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

August 17, 2020

Status Verified

August 1, 2020

Enrollment Period

2.4 years

First QC Date

April 30, 2018

Last Update Submit

August 13, 2020

Conditions

Von Willebrand Disease

Keywords

von Willebrand diseasevon Willebrand factorNationwide studyProspective study

Outcome Measures

Primary Outcomes (1)

  • Bleeding rate

    Number of bleedings in an individual divided by the follow-up duration

    2 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Von Willebrand disease patients known in a Hemophilia Treatment Center in the Netherlands

You may qualify if:

  • Historically lowest VWF:Ag and/or VWF:RCo and/or VWF:CB ≤ 0.30 IU/mL and/or FVIII:C ≤ 0.40 IU/mL
  • Treatment at a Hemophilia treatment center in the Netherlands
  • All types of VWD
  • All ages

You may not qualify if:

  • \- Other known bleeding disorders present.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Academic Medical Center

Amsterdam, Netherlands

NOT YET RECRUITING

Maxima Medical Center

Eindhoven, Netherlands

NOT YET RECRUITING

University Medical Center Groningen

Groningen, Netherlands

NOT YET RECRUITING

Leiden University Medical Center

Leiden, Netherlands

NOT YET RECRUITING

Maastricht University Medical Center +

Maastricht, Netherlands

NOT YET RECRUITING

Radboud University Medical Center

Nijmegen, Netherlands

NOT YET RECRUITING

Erasmus University Medical Center

Rotterdam, Netherlands

RECRUITING

Haga Hospital

The Hague, Netherlands

NOT YET RECRUITING

University Medical Center Utrecht

Utrecht, Netherlands

NOT YET RECRUITING

Related Publications (8)

  • Leebeek FW, Eikenboom JC. Von Willebrand's Disease. N Engl J Med. 2016 Nov 24;375(21):2067-2080. doi: 10.1056/NEJMra1601561. No abstract available.

    PMID: 27959741BACKGROUND

  • Sanders YV, Groeneveld D, Meijer K, Fijnvandraat K, Cnossen MH, van der Bom JG, Coppens M, de Meris J, Laros-van Gorkom BA, Mauser-Bunschoten EP, Leebeek FW, Eikenboom J; WiN study group. von Willebrand factor propeptide and the phenotypic classification of von Willebrand disease. Blood. 2015 May 7;125(19):3006-13. doi: 10.1182/blood-2014-09-603241. Epub 2015 Feb 11.

    PMID: 25673639BACKGROUND

  • de Wee EM, Mauser-Bunschoten EP, Van Der Bom JG, Degenaar-Dujardin ME, Eikenboom HC, Fijnvandraat K, de Goede-Bolder A, Laros-van Gorkom BA, Meijer K, Raat H, Leebeek FW; Win Study Group. Health-related quality of life among adult patients with moderate and severe von Willebrand disease. J Thromb Haemost. 2010 Jul;8(7):1492-9. doi: 10.1111/j.1538-7836.2010.03864.x. Epub 2010 Mar 23.

    PMID: 20345712BACKGROUND

  • de Wee EM, Sanders YV, Mauser-Bunschoten EP, van der Bom JG, Degenaar-Dujardin ME, Eikenboom J, de Goede-Bolder A, Laros-van Gorkom BA, Meijer K, Hamulyak K, Nijziel MR, Fijnvandraat K, Leebeek FW; WiN study group. Determinants of bleeding phenotype in adult patients with moderate or severe von Willebrand disease. Thromb Haemost. 2012 Oct;108(4):683-92. doi: 10.1160/TH12-04-0244. Epub 2012 Aug 23.

    PMID: 22918553BACKGROUND

  • van Galen KPM, de Kleijn P, Foppen W, Eikenboom J, Meijer K, Schutgens REG, Fischer K, Cnossen MH, de Meris J, Fijnvandraat K, van der Bom JG, Laros-van Gorkom BAP, Leebeek FWG, Mauser-Bunschoten EP; Win study group. Long-term impact of joint bleeds in von Willebrand disease: a nested case-control study. Haematologica. 2017 Sep;102(9):1486-1493. doi: 10.3324/haematol.2017.168617. Epub 2017 Jun 1.

    PMID: 28572165BACKGROUND

  • Sanders YV, Fijnvandraat K, Boender J, Mauser-Bunschoten EP, van der Bom JG, de Meris J, Smiers FJ, Granzen B, Brons P, Tamminga RY, Cnossen MH, Leebeek FW; WiN Study Group. Bleeding spectrum in children with moderate or severe von Willebrand disease: Relevance of pediatric-specific bleeding. Am J Hematol. 2015 Dec;90(12):1142-8. doi: 10.1002/ajh.24195. Epub 2015 Nov 17.

    PMID: 26375306BACKGROUND

  • van Galen KPM, Meijer K, Vogely HC, Eikenboom J, Schutgens REG, Cnossen MH, Fijnvandraat K, van der Bom JG, Laros-van Gorkom BAP, Leebeek FWG, Mauser-Bunschoten EP; WiN study group. Joint surgery in von Willebrand disease: a multicentre cross-sectional study. Haemophilia. 2016 Mar;22(2):256-262. doi: 10.1111/hae.12834. Epub 2015 Nov 9.

    PMID: 26551280BACKGROUND

  • Atiq F, Meijer K, Eikenboom J, Fijnvandraat K, Mauser-Bunschoten EP, van Galen KPM, Nijziel MR, Ypma PF, de Meris J, Laros-van Gorkom BAP, van der Bom JG, de Maat MP, Cnossen MH, Leebeek FWG; WiN study group. Comorbidities associated with higher von Willebrand factor (VWF) levels may explain the age-related increase of VWF in von Willebrand disease. Br J Haematol. 2018 Jul;182(1):93-105. doi: 10.1111/bjh.15277. Epub 2018 May 16.

    PMID: 29767844BACKGROUND

MeSH Terms

Conditions

von Willebrand Diseases

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersBlood Platelet DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Frank WG Leebeek, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

  • Ferdows Atiq, MD

    Erasmus Medical Center

    STUDY DIRECTOR

  • Marjon H Cnossen, MD, PhD

    Erasmus Medical Center

    STUDY CHAIR

  • Karin Fijnvandraat, MD, PhD

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

    STUDY CHAIR

  • Jeroen Eikenboom, MD, PhD

    Leiden University Medical Center

    STUDY CHAIR

  • Johanna G van der Bom, PhD

    Leiden University Medical Center

    STUDY CHAIR

  • Britta AP Laros-van Gorkom, MD, PhD

    Radboud University Medical Center

    STUDY CHAIR

  • Karina Meijer, MD, PhD

    University Medical Center Groningen

    STUDY CHAIR

  • Karin PM van Galen, MD, PhD

    UMC Utrecht

    STUDY CHAIR

  • Joke de Meris

    Netherlands Hemophilia Society

    STUDY CHAIR

Central Study Contacts

Frank WG Leebeek, MD, PhD

CONTACT

+31107031369f.leebeek@erasmusmc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 30, 2018

First Posted

May 11, 2018

Study Start

July 28, 2019

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

August 17, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

NL(9)