Minimally Invasive Surgery and rtPA for Intracerebral Hemorrhage Evacuation (MISTIE)
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ClinicalTrials.gov Identifier: NCT00224770 |
Recruitment Status :
Completed
First Posted : September 23, 2005
Results First Posted : June 18, 2015
Last Update Posted : June 18, 2015
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Intracerebral Hemorrhage |
Interventions |
Drug: MIS+Cathflo Activase (drug) Procedure: Intraoperative stereotactic CT-Guided Endoscopic Surgery |
Enrollment | 141 |
Recruitment Details | 110 patients were randomized to the trial, and 31 were recruited as pilot patients. |
Pre-assignment Details | 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. |
Arm/Group Title | Medical Management | MISTIE Surgical Management | ICES Surgical Management |
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Standard of care medical management as per American Heart Association (AHA) guidelines. |
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. |
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. |
Period Title: Overall Study | |||
Started | 42 | 54 | 14 |
Completed | 38 | 52 | 14 |
Not Completed | 4 | 2 | 0 |
Reason Not Completed | |||
Lost to Follow-up | 4 | 2 | 0 |
Arm/Group Title | Medical Management | MISTIE Surgical Management | ICES Surgical Management | Total | |
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Standard of care medical management as per American Heart Association (AHA) guidelines. |
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. |
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 of all reporting groups | |
Overall Number of Baseline Participants | 42 | 54 | 14 | 110 | |
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The decision was made to exclude the pilot patients from the analysis...
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 42 participants | 54 participants | 14 participants | 110 participants | |
<=18 years |
0 0.0%
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0 0.0%
|
0 0.0%
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0 0.0%
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Between 18 and 65 years |
18 42.9%
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25 46.3%
|
9 64.3%
|
52 47.3%
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>=65 years |
24 57.1%
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29 53.7%
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5 35.7%
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58 52.7%
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Age, Continuous
Median (Inter-Quartile Range) Unit of measure: Years |
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Number Analyzed | 42 participants | 54 participants | 14 participants | 110 participants | |
62
(49.5 to 73)
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60
(54 to 69)
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59
(53.2 to 68.2)
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61
(53.3 to 70)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 42 participants | 54 participants | 14 participants | 110 participants | |
Female |
14 33.3%
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19 35.2%
|
5 35.7%
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38 34.5%
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|
Male |
28 66.7%
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35 64.8%
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9 64.3%
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72 65.5%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 42 participants | 54 participants | 14 participants | 110 participants |
United States | 41 | 53 | 14 | 108 | |
United Kingdom | 1 | 1 | 0 | 2 |
Name/Title: | Dr. Daniel F. Hanley |
Organization: | Johns Hopkins University |
Phone: | (410) 614-6996 |
EMail: | dhanley@jhmi.edu |
Responsible Party: | Daniel Hanley, Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00224770 |
Other Study ID Numbers: |
ICH01 R01NS046309 ( U.S. NIH Grant/Contract ) |
First Submitted: | September 21, 2005 |
First Posted: | September 23, 2005 |
Results First Submitted: | September 21, 2014 |
Results First Posted: | June 18, 2015 |
Last Update Posted: | June 18, 2015 |