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Study was withdrawn from IRB review on 03/08/16
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This is single-arm, open-label, safety and feasibility pilot study of É›-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 É›-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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Study drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ɛ-Aminocaproic Acid | Drug | Intervention: intravenous ε-Aminocaproic Acid within 3 hours of symptom onset |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hematoma volume | 24 hours | |
| Lower extermity deep vein thrombosis on venous duplex ultrasound | 24-48 hours | |
| Evidence of cardiac ischemia on the electrocardiogram | 24 hours | |
| National Insitutes of Health Stroke Scale score | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Scale score | 30 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vivek Misra, MD | The University of Texas Health Science Center at San Antonio | Study Chair |
| Jean-Louis Caron, MD, FRCS(C) | The University of Texas Health Science Center at San Antonio | Study Director |
| Reza Behrouz, DO | The University of Texas Health Science Center at San Antonio | Principal Investigator |
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| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D015119 | Aminocaproic Acid |
| ID | Term |
|---|---|
| D000614 | Aminocaproates |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |