This is single-arm, open-label, safety and feasibility pilot study of ɛ-aminocaproic acid in ICH patients.
Consecutive ICH volume with hematoma volume less than 30 mL by ABC/2 method presenting within 3 hours of symptom onset, meeting all inclusion criteria, and without exclusions will be consented and enrolled. Subjects will receive 5 grams of intravenous ɛ-aminocaproic acid over 1 hour, followed by the same at 1 mg/hour for 23 hours. Comupted tomography (CT) head will be done at 24 hours in order to follow hematoma size. Electrocardiogram, lower extremity venous Doppler and NIHSS will also be done at 24 hours. The patient will be followed in the clinic 30-90 days post discharge for functional status.
Trial Stopped: Study was withdrawn from IRB review on 03/08/16
- ɛ-Aminocaproic Acid Drug
Other Names: Amicar; Aminocaproic Acid Intervention Desc: Intervention: intravenous ε-Aminocaproic Acid within 3 hours of symptom onset ARM 1: Kind: Experimental Label: Treatment Description: Study drug
- Masking: Open Label
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Single Group Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Hematoma volume||24 hours||No|
|Primary||Lower extermity deep vein thrombosis on venous duplex ultrasound||24-48 hours||Yes|
|Primary||Evidence of cardiac ischemia on the electrocardiogram||24 hours||Yes|
|Primary||National Insitutes of Health Stroke Scale score||24 hours||No|
|Secondary||Modified Rankin Scale score||30 Days||No|