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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Intracerebral Hemorrhage
• Intervention / Treatment: Drug: ɛ-Aminocaproic Acid

• Study Type: Interventional
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Study drug	Drug: ɛ-Aminocaproic Acid; Intervention: intravenous ε-Aminocaproic Acid within 3 hours of symptom onset; Other Names: Amicar; Aminocaproic Acid

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Modified Rankin Scale score	30 Days

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Investigators: Study Chair: Vivek Misra, MD, The University of Texas Health Science Center at San Antonio; Study Director: Jean-Louis Caron, MD, FRCS(C), The University of Texas Health Science Center at San Antonio

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2016
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: December 18, 2015
• First Submitted That Met QC Criteria: December 22, 2015
• First Posted (Estimate): December 24, 2015

Study Record Updates

• Last Update Posted (Actual): July 11, 2017
• Last Update Submitted That Met QC Criteria: July 5, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Stroke; Intracerebral Hemorrhage; Cerebrovascular
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Aminocaproic Acid
• Other Study ID Numbers: HSC20160096H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO