Investigating a Von Willebrand Factor (VWF) Functional Screening Assay for Assigning the Phenotypic Variants of Von Willebrand Disease (VWD)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02466789

Acronym

VWF-phV

Enrollment

134

Registered

2015-06-09

Start date

2015-07-31

Completion date

2022-06-30

Last updated

2022-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Von Willebrands Disease

Keywords

Bleeding Disorder, inherited, Von Willebrands Disease, Hematologic Test, VWF, VWD

Brief summary

The purpose of this study is to improve the investigators ability to diagnose von Willebrand Disease (VWD), a common inherited bleeding disorder. This study will look at a new screening blood test used to determine if a person has VWD. This new screening blood test can determine a diagnosis more rapidly than current blood tests. Also this test could be available at local hospital labs rather than require samples to be sent to bigger more specialized labs.

Detailed description

This investigation will be a prospective, multicenter trial to validate the clinical utility of a novel screening assay as a diagnostic screening assay for VWD variants: Type 1C, 2A, 2B, 2M and 2N. Once the subject is enrolled into the study, a minimum of 0.5ml of citrated plasma will be collected and analyzed at the Bleeding and Clotting Disorders Institute Laboratory in Peoria Illinois. Results will be collected: phenotype function profiles will be determined, statistically analyzed and compared to the qualitative data from Blood Center of Wisconsin. Data is expected to correlate as previously shown in prior studies and will confirm the utility of this assay.

Interventions

None listed

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to No maximum

Healthy volunteers

Inclusion criteria

* New subjects undergoing evaluation for the diagnosis of VWD determined to have a VWF:Ag or VWF: RCo \< 50 IU/dl and or a VWF:RCo/VWF:Ag of \<0.7. Also subjects will be included if Type 2 N VWD is clinically suspected

Exclusion criteria

* Those subjects whose lab results do not meet the inclusion criteria

Design outcomes

Primary

Measure	Time frame
Validate the novel ELISA-based VWF functional screening assay as a diagnostic screening assay to assign VWD phenotypes 1C, 2A, 2B, 2M and 2N.	planned analysis at 2 years and 4 years with study duration estimated at 4 years

Secondary

Measure	Time frame
Further development of the VWF functional screening assay through investigating the incorporation of VWF:CB6 (binding to collagen VI)	study duration 4 years

Countries

United States

Outcome results