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Impact of Acute ITTP Therapies on Long Term Neurologic and Cognitive Outcomes in ITTP Survivors
Sponsor: US Thrombotic Microangiopathy Alliance
Summary
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
116
Start Date
2024-12
Completion Date
2028-05
Last Updated
2024-11-13
Healthy Volunteers
No
Conditions
Interventions
Caplacizumab
Early Caplacizumab use
Locations (1)
USTMA
Groveport, Ohio, United States