1. We expect to find that the silent cerebral infarct (SCI) rate is two fold higher in patients treated without caplacizumab. We also expect to find that the rate of mild and major cognitive impairment in patients treated with caplacizumab within 3 days of starting plasma exchange will be lower than patients treated without caplacizumab. 2. We expect that the differences in cognitive impairment in cases (caplacizumab) versus controls (no caplacizumab) will persist on serial evaluation 1 year later. We also expect that there will be differences in these groups even after adjusting for time since episode and severity of presentation. 3. We expect to find that SCI and cognitive impairment is associated with worse scores on the health related quality of life instrument (SF-36) 4. Based on studies in non-TTP populations, we expect to find that the rate of incident stroke over the period of follow up is at least 2 fold higher in patients that have SCI compared with patients who do not have SCI
Study Type
OBSERVATIONAL
Enrollment
116
Early Caplacizumab use
USTMA
Groveport, Ohio, United States
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.
Time frame: 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
Time frame: 12 months
Depression scores on BDI-II
Time frame: 12 months
SF-36 scores for quality of life
Time frame: 12 months
Patient reported cognitive performance
(PROMIS Cognitive Function - Short form 8a)
Time frame: 12 months
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