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Minimally Invasive Surgery and rtPA for Intracerebral Hemorrhage Evacuation (MISTIE)

This study has been completed.
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Genentech, Inc.
Emissary International LLC
Information provided by (Responsible Party):
Daniel Hanley, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00224770
First received: September 21, 2005
Last updated: June 17, 2015
Last verified: June 2015
History of Changes
Results First Received: September 21, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Intracerebral Hemorrhage
Interventions: Drug: MIS+Cathflo Activase (drug)
Procedure: Intraoperative stereotactic CT-Guided Endoscopic Surgery

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
110 patients were randomized to the trial, and 31 were recruited as pilot patients.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Each study center was required to demonstrate proficiency in the technical aspects of enrollment, stabilization, surgery, and drug administration. This proficiency was demonstrated on at least one pilot patient prior to randomization of the first patient in the investigational cohort of 110 randomized patients.

Reporting Groups
  Description
Medical Management Standard of care medical management as per American Heart Association (AHA) guidelines.
MISTIE Surgical Management

Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).

MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.

This includes 54 intent-to-treat patients, and excludes 27 pilots.
ICES Surgical Management

Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)

Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.

This includes 14 intent-to-treat patients, and excludes 4 pilots.

Participant Flow:   Overall Study
    Medical Management     MISTIE Surgical Management     ICES Surgical Management  
STARTED     42     54     14  
COMPLETED     38     52     14  
NOT COMPLETED     4     2     0  
Lost to Follow-up                 4                 2                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The decision was made to exclude the pilot patients from the analysis...

Reporting Groups
  Description
Medical Management Standard of care medical management as per American Heart Association (AHA) guidelines.
MISTIE Surgical Management

Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).

MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo®) through the catheter once every eight hours for up to 72 hours, in addition to best medical care.

This includes 54 intent-to-treat patients, and excludes 27 pilots.
ICES Surgical Management

Intraoperative stereotactic CT-Guided Endoscopic Surgery

Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.

This includes 14 intent-to-treat patients, and excludes 4 pilots.
Total Total of all reporting groups

Baseline Measures
    Medical Management     MISTIE Surgical Management     ICES Surgical Management     Total  
Number of Participants  
[units: participants]
 		  42     54     14     110  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     18     25     9     52  
>=65 years     24     29     5     58  
Age  
[units: years]
Median (Inter-Quartile Range) 		  62  
  (49.5 to 73)   		  60  
  (54 to 69)   		  59  
  (53.2 to 68.2)   		  61  
  (53.3 to 70)  
Gender  
[units: participants]
 		       
Female     14     19     5     38  
Male     28     35     9     72  
Region of Enrollment  
[units: participants]
 		       
United States     41     53     14     108  
United Kingdom     1     1     0     2  



  Outcome Measures
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1.  Primary:   Safety Outcome Number 1: Rate of Mortality   [ Time Frame: 30 days from randomization ]
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2.  Primary:   Safety Outcome Number 2: Rate of Procedure-related Mortality   [ Time Frame: 7 days from randomization ]
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3.  Primary:   Safety Outcome Number 3: Rate of Cerebritis, Meningitis, Bacterial Ventriculitis   [ Time Frame: 30 days from randomization ]
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4.  Primary:   Safety Outcome Number 4: Rate of Symptomatic Rebleeding   [ Time Frame: 72 hours post last dose ]
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5.  Primary:   Efficacy Outcome Number 1: Dichotomized Modified Rankin Scale (mRS) at Day 180   [ Time Frame: 180 days from randomization ]
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6.  Secondary:   Ordinal Modified Rankin Scale (mRS) at Day 180   [ Time Frame: 180 days from randomization ]
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7.  Secondary:   Ordinal Modified Rankin Scale (mRS) at Day 365   [ Time Frame: 365 days from randomization ]
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8.  Secondary:   Clot Size Reduction by End of Treatment   [ Time Frame: Time from randomization until end of treatment, up to 10 days ]
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9.  Secondary:   Post-operative Clot Size Reduction   [ Time Frame: Time from post-operation until end of treatment, up to 10 days ]
  Show Outcome Measure 9


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Daniel F. Hanley
Organization: Johns Hopkins University
phone: (410) 614-6996
e-mail: dhanley@jhmi.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Daniel Hanley, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00224770     History of Changes
Other Study ID Numbers: ICH01
R01NS046309 ( US NIH Grant/Contract Award Number )
Study First Received: September 21, 2005
Results First Received: September 21, 2014
Last Updated: June 17, 2015
Health Authority: United States: Food and Drug Administration