Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358703
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-04-04
Brief Title:
Impact of Acute iTTP Therapies on Long Term Neurologic and Cognitive Outcomes in iTTP Survivors
Sponsor:
US Thrombotic Microangiopathy Alliance
Organization:
US Thrombotic Microangiopathy Alliance
Study Overview
Official Title:
Impact of Acute iTTP Therapies on Long Term Neurologic and Cognitive Outcomes in iTTP Survivors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
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:
NeST
Brief 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
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
Detailed Description:
None
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