Ignite Creation Date:
2024-05-06 @ 4:31 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05015244
Status:
UNKNOWN
Last Update Posted:
2022-08-24
First Post:
2021-07-20
Brief Title:
Impact of Von Willebrand Factor-platelet Aggregates in Patients With Type 2B Disease
Sponsor:
University Hospital Caen
Organization:
University Hospital Caen
Study Overview
Official Title:
Impact of Von Willebrand Factor-platelet Aggregates in Patients With Type 2B Disease
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Von2B
Brief Summary:
The working hypothesis is that patients with Von Willebrand Disease-type 2B may have neurological symptoms due to the chronic formation of plateletsVon Willebrand Factor aggregates Interestingly several patients present nonspecific neurological symptoms nystagmus headaches memory disorder which may be associated with cerebral microangiopathy and chronic microvessel inflammation secondary to Von Willebrand Disease-type 2B due to chronic exposure to Von Willebrand Factor-platelets complexes
Detailed Description:
Investigator will use an extensive series of neuropsychological tests that cover virtually all cognitive domains A measurement of global cognitive function will be assessed by the Mini Mental State Examination MMSE The verbal memory function will be assessed by the Rey Auditory Verbal Learning Test RAVLT Visuospatial memory will be administered by the Reys Complex Figure Test RCFT To evaluate speed of mental processes Stroop test three subtasks the Paper and Pencil Memory Scanning Task four subtasks the Symbol-Digit Substitution Task will be used To evaluate attention the verbal series attention test VSAT will be used To register subjective cognitive failures investigator will administer the Cognitive failures questionnaire CFQ The neurological evaluation will be completed with 3T Tesla Magnetic Resonance Imaging MRI with different MRI sequences including T1 3D SPACE FLAIR 3D 3D SWI Susceptibility weighted imaging and 2D EPI Echo Planar Imaging to address the presence of cerebral small vessel disease The presence of each of the four MRI markers for cerebral small vessel disease white matter hyperintensities lacunes cerebral microbleeds and perivascular spaces will be addressed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None