Impact of Acute ITTP Therapies on Long Term Neurologic and Cognitive Outcomes in ITTP Survivors

Conditions

• Immune Thrombotic Thrombocytopenia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Caplacizumab — DRUG
  Early Caplacizumab use

Study Details

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 Dates

Start date

Dec 31, 2024

Status verified

Apr 2024

Primary completion

May 31, 2027

Completion

May 31, 2028

Study Design

Enrollment

116 participants (estimated)

Arms

• Arm: Cases
• Arm: Controls

Primary Outcome Measure

Silent cerebral infarction [ Time Frame: 12 months ]

Locations (1)

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