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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Recruitment Status : Withdrawn (Study was withdrawn from IRB review on 03/08/16)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

Tracking Information
First Submitted Date  ICMJE December 18, 2015
First Posted Date  ICMJE December 24, 2015
Last Update Posted Date July 11, 2017
Estimated Study Start Date  ICMJE June 2016
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2015)
  • Hematoma volume [ Time Frame: 24 hours ]
  • Lower extermity deep vein thrombosis on venous duplex ultrasound [ Time Frame: 24-48 hours ]
  • Evidence of cardiac ischemia on the electrocardiogram [ Time Frame: 24 hours ]
  • National Insitutes of Health Stroke Scale score [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02639819 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2015)
Modified Rankin Scale score [ Time Frame: 30 Days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Management of Intracerebral Hemorrhage With Aminocaproic Acid - Pilot Study
Official Title  ICMJE A Pilot Study of Ultra-Early Intravenous ɛ-Aminocaproic Acid in Spontanteous Intracerebral Hemorrhage
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Intracerebral Hemorrhage
Intervention  ICMJE Drug: ɛ-Aminocaproic Acid
Intervention: intravenous ε-Aminocaproic Acid within 3 hours of symptom onset
Other Names:
  • Amicar
  • Aminocaproic Acid
Study Arms  ICMJE Experimental: Treatment
Study drug
Intervention: Drug: ɛ-Aminocaproic Acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 5, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: December 22, 2015)
40
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02639819
Other Study ID Numbers  ICMJE HSC20160096H
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party The University of Texas Health Science Center at San Antonio
Study Sponsor  ICMJE The University of Texas Health Science Center at San Antonio
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP