NCT02639819

Management of Intracerebral Hemorrhage With Aminocaproic Acid - Pilot Study

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intracerebral Hemorrhage

Interventions

Type	Name	Description
DRUG	ɛ-Aminocaproic Acid	Intervention: intravenous ε-Aminocaproic Acid within 3 hours of symptom onset

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-07-01
• Completion: 2017-12-01
• First posted: 2015-12-24
• Last updated: 2017-07-11