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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases |
| ||
| Controls |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caplacizumab | Drug | Early Caplacizumab use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Silent cerebral infarction | Silent cerebral infarction (primary endpoint) - SCI is derived from quantitation (number and total volume) of ischemic (infarct-like) lesions shown as foci of T2 and FLAIR hyperintensity. SCI is diagnosed if the participant has an infarct like lesion, at least 3 mm, with normal neurologic examination or an abnormality on examination that is not explained by the location of the brain lesion. We have assembled a panel of 3 neuroradiologists headed by Dr. Doris Lin. Each MRI will be read by 2 radiologists. A third reviewer will serve as a tie breaker in case of disagreement. | 12 months |
| Cognitive impairment | Cognitive impairment (co-primary endpoint) - measured using NIH ToolBox Cognition Battery. Mild and major cognitive impairment are defined as T scores that are 1-2 SD below mean and > 2SD below mean for any domain, respectively | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Depression scores on BDI-II | 12 months | |
| SF-36 scores for quality of life | 12 months | |
| Patient reported cognitive performance |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with iTTP
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USTMA | Groveport | Ohio | 43125 | United States |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C585343 | caplacizumab |
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Plasma will be held in a biobank
(PROMIS Cognitive Function - Short form 8a) |
| 12 months |