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 ICES arm of the trial will determine the safety of endoscopic surgery to remove ICH. All MISTIE intention to treat subjects represent the hypothesized test group. The ICES cohort is to be analyzed separately.
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. The Intraoperative stereotactic CT-guided Endoscopic Surgery (ICES) arm of the trial will determine the safety, feasibility and effectiveness of endoscopic surgery to remove ICH. This tests the first step of the MISTIE surgical procedure with an endoscope, not a rigid cannula. We propose to test if these interventions facilitate 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 these interventions and assess their ability to remove blood clot from brain tissue.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
141
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.
Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative targeting arm as MISTIE arm. No rt-PA administered, and in addition to best medical care.
Safety Outcome Number 1: Rate of Mortality
Percentage of participants who died during the first 30 days after randomization.
Time frame: 30 days from randomization
Safety Outcome Number 2: Rate of Procedure-related Mortality
Percentage of participants who died during the first 7 days after randomization.
Time frame: 7 days from randomization
Safety Outcome Number 3: Rate of Cerebritis, Meningitis, Bacterial Ventriculitis
Percentage of participants who had a bacterial brain infection (cerebritis, meningitis, ventriculitis) within 30 days of randomization.
Time frame: 30 days from randomization
Safety Outcome Number 4: Rate of Symptomatic Rebleeding
The difference in the rate of symptomatic rebleeding 72 hours post last dose.
Time frame: 72 hours post last dose
Efficacy Outcome Number 1: Dichotomized Modified Rankin Scale (mRS) at Day 180
Percentage of participants with dichotomized mRS score in 0-3 range. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead
Time frame: 180 days from randomization
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Barrow Neurosurgical Associates
Phoenix, Arizona, United States
University of California Los Angeles
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
University of California, San Diego
San Diego, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Georgetown University
Washington D.C., District of Columbia, United States
Mayo Clinic
Jacksonville, Florida, United States
Rush University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
...and 19 more locations
Ordinal Modified Rankin Scale (mRS) at Day 180
Ordinal distribution of the Modified Rankin Scale score at 180 days. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead.
Time frame: 180 days from randomization
Ordinal Modified Rankin Scale (mRS) at Day 365
Ordinal distribution of the Modified Rankin Scale score at 365 days. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead.
Time frame: 365 days from randomization
Clot Size Reduction by End of Treatment
The percentage of blood clot resolved by the end of treatment CT scan compared to the stability CT scan.
Time frame: Time from randomization until end of treatment, up to 10 days
Post-operative Clot Size Reduction
The percentage of blood clot resolved by the end of treatment CT scan compared to the post-operative CT scan for surgical patients.
Time frame: Time from post-operation until end of treatment, up to 10 days