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Minimally Invasive Surgery Plus rtPA for Intracerebral Hemorrhage Evacuation (MISTIE)
This study is currently recruiting participants.
Verified by Johns Hopkins University, April 2008
First Received: September 21, 2005   Last Updated: April 1, 2008   History of Changes
Sponsors and Collaborators: Johns Hopkins University
National Institutes of Health (NIH)
Genentech
Information provided by: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00224770
  Purpose

The purpose of this trial is to determine the safety of using a combination of minimally invasive surgery and clot lysis with rt-PA to remove intracerebral hemorrhage (ICH). The procedure is to use image-based surgery (MRI or CT) to provide catheter access to ICH for the intervention, which is a one-time clot aspiration followed by instillation of rt-PA over 72 hours. We propose to test if this intervention facilitates more rapid and complete recovery of function and decreased mortality from this condition compared to conventional medical management without subjecting the patient to craniotomy. The specific objective of this trial is to test the safety of this intervention and assess its ability to remove blood clot from brain tissue.


Condition Intervention Phase
Intracerebral Hemorrhage
Drug: Cathflo Activase (drug)
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title: Minimally Invasive Surgery Plus rtPA for Intracerebral Hemorrhage Evacuation (MISTIE)

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 30-day mortality
  • Procedure related mortality
  • Incidence of cerebritis, meningitis
  • Rate of rebleeding

Secondary Outcome Measures:
  • Rate of clot size reduction at Days 4-5 determined by CT scans
  • 90 & 180 day GOS, Rankin, Stroke Impact Scale

Estimated Enrollment: 110
Study Start Date: August 2005
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-80
  • GCS < 14 or a NIHSS > 6
  • Spontaneous supratentorial ICH > 25cc
  • Symptoms less than 12 hours prior to diagnostic CT scan (an unknown time of symptom onset is exclusionary)
  • First dose can be given within 36 hours of symptom onset (plus a 2-hour feasibility window with approval from the coordinating center, reserved for only those situations where the patient is eligible, consented, stable but personnel scheduling prohibits giving the first dose within the 36-hour window)
  • Six-hour clot size equal to the most previous clot size + 5 cc (as determined by an additional CT scan at least 6 hours after the initial stability scan (A*B*C)/2 method)
  • SBP < 200 mmHg sustained for 6 hours
  • Historical Rankin score of 0 or 1
  • Negative pregnancy test

Exclusion Criteria:

  • Infratentorial hemorrhage (any involvement of the midbrain or lower brainstem as demonstrated by radiograph or complete third nerve palsy)
  • Patients with platelet count < 100,000, INR > 1.7, PT > 15s, or an elevated APTT (reversal of coumadin is permitted but the patient must not require coumadin during the acute hospitalization), Irreversible coagulopathy either due to medical condition or prior to randomization
  • Clotting disorders
  • Any concurrent serious illness that would interfere with the safety assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease
  • Patients with a mechanical valve
  • Patients with unstable mass or evolving intracranial compartment syndrome
  • Ruptured aneurysm, AVM, vascular anomaly
  • Greater than 80 years (higher incidence of amyloid)
  • Under 18 years of ag e (high incidence of occult vascular malformation)
  • Pregnant (positive pregnancy test) or lactating females (likelihood of altered coagulation function associated with the high estrogen/progesterone state)
  • Irreversibly impaired brainstem function (bilateral fixed, dilated pupils and extensor motor posturing), GCS less than or equal to 4
  • Historical Rankin score greater than or equal to 2
  • Intraventricular hemorrhage requiring external ventricular drainage
  • Internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts
  • Superficial or surface bleeding, observed mainly at vascular puncture and access sites (e.g., venous cutdowns, arterial punctures) or site of recent surgical intervention
  • Known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, and subacute bacterial endocarditis
  • In the investigator's opinion, the patient is unstable and would benefit from a specific intervention rather than supportive care plus or minus MIS+rtPA
  • Prior enrollment in the study
  • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
  • Participation in another simultaneous trial of ICH treatment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00224770

Contacts
Contact: Nichol McBee, MPH, CCRP 410-614-6996 nmcbee@jhmi.edu

Locations
United States, Illinois
Evanston Northwestern Healthcare Recruiting
Evanston, Illinois, United States, 60201
Contact: Judith O'Leary, RN     847-570-1632     JOLeary@enh.org    
Principal Investigator: Issam Awad, MD            
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Shannon Le Droux     410-502-0505     sledrou1@jhmi.edu    
Principal Investigator: Rafael Tamargo, MD            
Principal Investigator: Richard Clatterbuck, MD            
Sub-Investigator: Judy Huang, MD            
Sub-Investigator: Neal Naff, MD            
University of Maryland Medical Systems Recruiting
Baltimore, Maryland, United States
Contact: Charlene Aldrich, RN     410-328-5332     CALDRICH@smail.umaryland.edu    
Principal Investigator: Francois Aldrich, MD            
United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Flicia Mada, RN     313-745-1893     fmada@med.wayne.edu    
Principal Investigator: William Coplin, MD            
Principal Investigator: Robert Johnson, MD            
United States, Missouri
Washington University Recruiting
St. Louis, Missouri, United States, 63110
Contact: Brenda Hall     314-362-3559        
Principal Investigator: Greg Zipfel, MD            
United States, New York
Mt. Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Fatima Sehba, PhD     212-241-6504     fatima.sehba@mssm.edu    
Principal Investigator: Joshua Bederson, MD            
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Suzanne Kempisty-Cliver, RN     513-558-3590     kempiss@ucmail.uc.edu    
Principal Investigator: Mario Zuccarello, MD            
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Bonnie Muntz-Pope, RN     843-792-8967     muntzpob@musc.edu    
Principal Investigator: Byron Bailey, MD            
Sub-Investigator: Marc Lapointe, PharmD            
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Randall Merchant, PhD     804-828-9528     rmerchan@hsc.vcu.edu    
Principal Investigator: William Broaddus, MD            
Sponsors and Collaborators
Johns Hopkins University
Genentech
Investigators
Study Chair: Daniel F. Hanley, MD Johns Hopkins University
Principal Investigator: Mario Zuccarello, MD University of Cincinnati
  More Information

No publications provided

Study ID Numbers: ICH01, 1 R01 NS046309-01 A1
Study First Received: September 21, 2005
Last Updated: April 1, 2008
ClinicalTrials.gov Identifier: NCT00224770     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Fibrin Modulating Agents
Cerebral Hemorrhage
Vascular Diseases
Tissue Plasminogen Activator
Central Nervous System Diseases
Fibrinolytic Agents
Cardiovascular Agents
Intracranial Hemorrhages
Brain Diseases
Hemorrhage
Plasminogen
Cerebrovascular Disorders

Additional relevant MeSH terms:
Cerebral Hemorrhage
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Tissue Plasminogen Activator
Fibrinolytic Agents
Cardiovascular Agents
Intracranial Hemorrhages
Hemorrhage
Brain Diseases
Cerebrovascular Disorders
Pharmacologic Actions
Fibrin Modulating Agents
Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 02, 2009