Intracerebral Hemorrhage
Conditions
Keywords
Intracerebral Hemorrhage, Stroke, Cerebrovascular
Brief summary
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.
Interventions
DRUGɛ-Aminocaproic Acid
Intervention: intravenous ε-Aminocaproic Acid within 3 hours of symptom onset
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18-80 years 2. Supratentorial ICH ≤ 30 mL in volume and seen on ≥ 2 slices on a 0.5 mm CT head 3. IVH involving \< 50% of the ipsilateral lateral ventricle will be allowed 4. Treatment initiated within 1 hour of baseline CT and 3 hours of onset or last known normal
Exclusion criteria
1. Baseline mRS ≥ 2 2. Infratentorial hemorrhage (brainstem/cerebellum) 3. Any supratentorial hemorrhage extending to the brainstem 4. ICH \> 30 mL 5. Patients who undergo surgical evacuation 6. Presenting outside of the 3 hour window 7. Intraventricular extension \> 1/2 of one lateral ventricle 8. Intraventricular extension into the 3rd or 4th ventricle, or the aqueduct or involving \>50% of the ipsilateral lateral ventricle 9. ICH due to trauma 10. ICH due to aneurysm of arteriovenous malformation 11. ICH due to underlying neoplasm or infectious mass 12. ICH due to Warfarin or other oral or intravenous anticoagulants 13. International normalization ratio \> 1.4 14. Life expectancy \< 1 year (prior to ICH onset); due to any cause. 15. History of recent ischemic stroke (within the past 3 months) 16. History of deep vein thrombosis or pulmonary embolism 17. History of recent myocardial infarction (within the past 3 months) 18. Known history of hypercoagulable state 19. History of cancer 20. Glomerular filtration rate \< 60 mL/min 21. Received any hemostatic therapy for any indication (last 14 days) 22. Received any investigational therapy in last 90 days 23. Do Not Resuscitate order in place or expected, advance directives that could limit aggressive treatment measures.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Modified Rankin Scale score | 30 Days |
Outcome results
None listed