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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02639819
Recruitment Status : Withdrawn (Study was withdrawn from IRB review on 03/08/16)
First Posted : December 24, 2015
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Intracerebral Hemorrhage Drug: ɛ-Aminocaproic Acid Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Ultra-Early Intravenous ɛ-Aminocaproic Acid in Spontanteous Intracerebral Hemorrhage
Estimated Study Start Date : June 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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




Primary Outcome Measures :
  1. Hematoma volume [ Time Frame: 24 hours ]
  2. Lower extermity deep vein thrombosis on venous duplex ultrasound [ Time Frame: 24-48 hours ]
  3. Evidence of cardiac ischemia on the electrocardiogram [ Time Frame: 24 hours ]
  4. National Insitutes of Health Stroke Scale score [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Modified Rankin Scale score [ Time Frame: 30 Days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639819


Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
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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
Principal Investigator: Reza Behrouz, DO The University of Texas Health Science Center at San Antonio

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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02639819     History of Changes
Other Study ID Numbers: HSC20160096H
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by The University of Texas Health Science Center at San Antonio:
Intracerebral Hemorrhage
Stroke
Cerebrovascular
Additional relevant MeSH terms:
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Aminocaproic Acid
Cerebral Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants