Investigating a Von Willebrand Factor (VWF) Functional Screening Assay for Assigning the Phenotypic Variants of Von Willebrand Disease (VWD) (VWF-phV)
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ClinicalTrials.gov Identifier: NCT02466789
Recruitment Status :
Active, not recruiting
First Posted : June 9, 2015
Last Update Posted : August 6, 2019
Information provided by (Responsible Party):
Jonathan Roberts, Bleeding and Clotting Disorders Institute Peoria, Illinois
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.
Condition or disease
Von Willebrands Disease
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.
Validate the novel ELISA-based VWF functional screening assay as a diagnostic screening assay to assign VWD phenotypes 1C, 2A, 2B, 2M and 2N. [ Time Frame: planned analysis at 2 years and 4 years with study duration estimated at 4 years ]
Secondary Outcome Measures :
Further development of the VWF functional screening assay through investigating the incorporation of VWF:CB6 (binding to collagen VI) [ Time Frame: study duration 4 years ]
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Layout table for eligibility information
Ages Eligible for Study:
2 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
New subjects undergoing evaluation for the diagnosis of VWD that are determined to have VWF:ag or VWF:RCo <50 IU/dl and or a VWF:RCo/VWF:ag ratio of <0.7. Also subjects will be included if Type 2N VWD is suspected
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
Those subjects whose lab results do not meet the inclusion criteria