Management of Intracerebral Hemorrhage With Aminocaproic Acid - Pilot Study

NCT02639819 | Withdrawn Phase 1 DMC

• 1 other identifier: HSC20160096H
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intracerebral Hemorrhage

Keywords

Intracerebral Hemorrhage; Stroke; Cerebrovascular

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Modified Rankin Scale score

  30 Days

Study Arms (1)

Treatment

EXPERIMENTAL

Study drug

Drug: ɛ-Aminocaproic Acid

Interventions

ɛ-Aminocaproic Acid DRUG

Intervention: intravenous ε-Aminocaproic Acid within 3 hours of symptom onset

Also known as: Amicar, Aminocaproic Acid

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years
• Supratentorial ICH ≤ 30 mL in volume and seen on ≥ 2 slices on a 0.5 mm CT head
• IVH involving \< 50% of the ipsilateral lateral ventricle will be allowed
• Treatment initiated within 1 hour of baseline CT and 3 hours of onset or last known normal

You may not qualify if:

• Baseline mRS ≥ 2
• Infratentorial hemorrhage (brainstem/cerebellum)
• Any supratentorial hemorrhage extending to the brainstem
• ICH \> 30 mL
• Patients who undergo surgical evacuation
• Presenting outside of the 3 hour window
• Intraventricular extension \> 1/2 of one lateral ventricle
• Intraventricular extension into the 3rd or 4th ventricle, or the aqueduct or involving \>50% of the ipsilateral lateral ventricle
• ICH due to trauma
• ICH due to aneurysm of arteriovenous malformation
• ICH due to underlying neoplasm or infectious mass
• ICH due to Warfarin or other oral or intravenous anticoagulants
• International normalization ratio \> 1.4
• Life expectancy \< 1 year (prior to ICH onset); due to any cause.
• History of recent ischemic stroke (within the past 3 months)

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

MeSH Terms

Conditions

Cerebral Hemorrhage; Stroke

Interventions

Aminocaproic Acid

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminocaproates; Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Vivek Misra, MD

  The University of Texas Health Science Center at San Antonio

  STUDY CHAIR

• Jean-Louis Caron, MD, FRCS(C)

  The University of Texas Health Science Center at San Antonio

  STUDY DIRECTOR

• Reza Behrouz, DO

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: December 24, 2015
• Study Start: June 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 11, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share