Management of Intracerebral Hemorrhage With Aminocaproic Acid - Pilot Study

Phase 1

Withdrawn

• Conditions: Intracerebral Hemorrhage
• Interventions: Drug: ɛ-Aminocaproic Acid

• Registration Number: NCT02639819
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-18
• Study First Submitted QC: 2015-12-22
• Study First Posted: 2015-12-24
• Study Start: 2016-06
• Status Verified: 2017-07
• Primary Completion: 2017-07
• Last Update Submitted: 2017-07-05
• Last Update Posted: 2017-07-11
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	ɛ-Aminocaproic Acid	Study drug

Primary Outcome Measures

Name	Time	Method
Hematoma volume	24 hours
National Insitutes of Health Stroke Scale score	24 hours
Lower extermity deep vein thrombosis on venous duplex ultrasound	24-48 hours
Evidence of cardiac ischemia on the electrocardiogram	24 hours

Secondary Outcome Measures

Name	Time	Method
Modified Rankin Scale score	30 Days