Investigating a Von Willebrand Factor (VWF) Functional Screening Assay for Assigning the Phenotypic Variants of Von Willebrand Disease (VWD)
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 2 - Any |
Updated: | 4/17/2018 |
Start Date: | July 2015 |
End Date: | December 2019 |
Contact: | Jonathan Roberts, MD |
Email: | jroberts@ilbcdi.org |
Phone: | 309-692-5337 |
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.
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.
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.
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.
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
We found this trial at
1
site
Peoria, Illinois 61614
Principal Investigator: Jonathan Roberts, MD
Phone: 309-692-5337
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