Management of Intracerebral Hemorrhage With Aminocaproic Acid - Pilot Study

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Study of Ultra-Early Intravenous ɛ-Aminocaproic Acid in Spontanteous Intracerebral Hemorrhage

Conditions
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Intracerebral Hemorrhage

Intervention / Treatment
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* Drug: ɛ-Aminocaproic Acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80 years Supratentorial ICH ≤ 30 mL in volume and seen on ≥ 2 slices on a 0.5 mm CT head IVH involving < 50% of the ipsilateral lateral ventricle will be allowed Treatment initiated within 1 hour of baseline CT and 3 hours of onset or last known normal Exclusion Criteria: Baseline mRS ≥ 2 Infratentorial hemorrhage (brainstem/cerebellum) Any supratentorial hemorrhage extending to the brainstem ICH > 30 mL Patients who undergo surgical evacuation Presenting outside of the 3 hour window Intraventricular extension > 1/2 of one lateral ventricle Intraventricular extension into the 3rd or 4th ventricle, or the aqueduct or involving >50% of the ipsilateral lateral ventricle ICH due to trauma ICH due to aneurysm of arteriovenous malformation ICH due to underlying neoplasm or infectious mass ICH due to Warfarin or other oral or intravenous anticoagulants International normalization ratio > 1.4 Life expectancy < 1 year (prior to ICH onset); due to any cause. History of recent ischemic stroke (within the past 3 months) History of deep vein thrombosis or pulmonary embolism History of recent myocardial infarction (within the past 3 months) Known history of hypercoagulable state History of cancer Glomerular filtration rate < 60 mL/min Received any hemostatic therapy for any indication (last 14 days) Received any investigational therapy in last 90 days Do Not Resuscitate order in place or expected, advance directives that could limit aggressive treatment measures.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Study drug | Drug: ɛ-Aminocaproic Acid<br>* Intervention: intravenous ε-Aminocaproic Acid within 3 hours of symptom onset<br>* Other names: Aminocaproic Acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale score |  | 30 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intracerebral Hemorrhage, Stroke, Cerebrovascular