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The Severe Von Willebrand Disease Patient Registry: A Longitudinal Natural History and Patient Outcomes Study

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

A web-based registry will be created by the sponsor, VWD Connect Foundation (VCF), to collect data on patients with severe Von Willebrand Disease (sVWD). Data will be self-reported by patients and/or collected by registry personnel, as appropriate. The purpose of the sVWD Patient Registry is to create a database of well-characterized (with respect to demographics, medical history, symptoms, laboratory and genetic data, etc.) patients with sVWD for participation in retrospective and prospective research.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Anyone meeting the diagnostic classification for von Willebrand disease

• Any VWF antigen or activity:

• a. Result \<20% regardless of bleeding phenotype, or b. Result \<30% with excessive bleeding symptoms including: i. Bleeding that resulted in hospitalization, required surgical procedure, red blood cell transfusion, Hemoglobin decrease \>2g/dL, or ii. Intracranial, intraspinal, pericardial, retroperitoneal, intramuscular bleeding with compartment syndrome, or iii. Persistent or recurrent bleeding that is disruptive of work or school.

• Provide informed consent by participant or legally authorized representative

• Be willing and able to comply with study procedures and data collection

• Reside in the United States

⁃ NOTE: For inclusion criteria 1 and 2, it is not expected that participants will submit evidence of clinical diagnosis at screening; a participant's own confirmation that they have severe VWD will be sufficient for meeting the enrollment requirement and obtaining access to the registry. Laboratory values will be provided during the conduct of the study, and participants with VWF antigen or activity not meeting inclusion criterion 2 may be excluded from data analysis on a case-by-case basis in consultation with a subcommittee of the VWD Connect Foundation Medical and Scientific Advisory Board.

Locations
United States
Florida
VWD Connect Foundation
RECRUITING
Wellington
Contact Information
Primary
Christina Morgenthaler, MS, MBA
morgenthaler@vwdregistry.org
(279) 346-6202
Time Frame
Start Date: 2021-12-10
Estimated Completion Date: 2031-12
Participants
Target number of participants: 400
Authors
Alice Arapshian
Sponsors
Leads: VWD Connect Foundation

This content was sourced from clinicaltrials.gov