Management of Intracerebral Hemorrhage With Aminocaproic Acid - Pilot Study "MANICHAN-PILOT"

Withdrawn

Phase 1 Results N/A

Trial Description

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.

Trial Stopped: Study was withdrawn from IRB review on 03/08/16

Conditions

Interventions

  • ɛ-Aminocaproic Acid Drug
    Other Names: Amicar; Aminocaproic Acid
    Intervention Desc: Intervention: intravenous ε-Aminocaproic Acid within 3 hours of symptom onset
    ARM 1: Kind: Experimental
    Label: Treatment
    Description: Study drug

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Hematoma volume 24 hours No
Primary Lower extermity deep vein thrombosis on venous duplex ultrasound 24-48 hours Yes
Primary Evidence of cardiac ischemia on the electrocardiogram 24 hours Yes
Primary National Insitutes of Health Stroke Scale score 24 hours No
Secondary Modified Rankin Scale score 30 Days No

Sponsors