The Site Assessment & Suitability Survey (SASS) form has not been ported to our new website. The online form has been moved to the VISION-EDC system. However, if you do not yet have access to the EDC, you can complete the paper (MSWord) version.

ICES is the third tier of the MISTIE phase-II trial. In this tier, intraventricular hemorrhage patients underwent stereotactic-guided endoscopic evacuation rather than thrombolysis. All other aspects of the trial, including the 6-month and 12-month neurological outcome assessments, are identical, allowing a comparison between endoscopic evaluation, pharmacologic therapy and standard medical care. The Surgical Coordinating Center for ICES was at the University of California Los Angeles (UCLA), under the direction of Principal Investigator Dr. Paul Vespa. Enrollment in the ICES tier is closed. The last of 18 enrolled endoscopy patients completed the 12-month follow-up in April-2013. Results will be published soon.

ClinicalTrials.gov Identifier:

QUICK DOWNLOADS

This page contains links to the most popular MISTIE III study documents, forms and templates. If you don't find it here, please look in the full download repository or SEARCH. You must be logged-in to see and download certain documents in this list (such as the protocol).

Name File size    
MISTIE-III Protocol 4.0 Clean 1.89 MB

MISTIE III Informed Consent Guide 135.78 KB

Intracerebral hemorrhage (ICH) is a sudden bleeding into brain tissue which can have devastating results. It is a world-wide problem for which there is currently no effective treatment. MISTIE III (Minimally Invasive Surgery Plus rt-PA for Intracerebral Hemorrhage Evacuation) is an international, phase 3, 500-patient clinical trial with the primary goal of defining a successful treatment for ICH.  

The MISTIE III intervention seeks to remove blood from the brain through minimally invasive surgery and intermittent dosing of a clot-busting drug, a recombinant tissue plasminogen activator (rt-PA) called alteplase. The study premise is that by removing the blood clot faster, injury to the brain will be reduced and the patient’s long-term prognosis will improve. 

MISTIE III is the result of over 10 years of preliminary research and clinical trials. An earlier study, MISTIE II, was completed in April 2013. That study suggests that this investigational treatment may offer a possible new treatment for this devastating condition. This next study, MISTIE III, was designed to confirm these preliminary findings in a larger number of patients. The hope is that the MISTIE approach can improve patient's long-term quality of life. The primary endpoint is a outcomes assessment called the Modified Rankin Score measured at 180 and 365 days after the stroke.

MISTIE III is funded by the National Institute of Neurological Disorders and Stroke (NINDS), one of the National Institutes of Health (NIH), under a cooperative agreement (U01). It will involve over 90 centers in the US, Europe, Israel, China and Australia.  The trial is led by Study Chairman and Co-Principal Investigator Dr. Daniel Hanley of Johns Hopkins University and coordinated by the Brain Injury Outcomes service (BIOS) in the Department of Neurology. There are two surgical coordinating centers: University of Chicago, led by Co-Principal Investigator Dr. Issam Awad, and the University of Cincinnati, led by Co-Principal Investigator Dr. Mario Zuccarello.

ClinicalTrials.gov Identifier:
NCT01827046

International Standard Randomised Controlled Trial Number Register (ISRCTN) Identifier:
ISRCTN81927110

 NIH/NINDS Cooperative Agreement:
1U01NS080824-01A1

Protocol and SAP:
MISTIE_III_Protocol_SAP.pdf

 

Intracerebral hemorrhage (ICH) is the only major stroke subtype without a clearly effective treatment. ICH occurs in over 100,000 Americans yearly. African Americans, Hispanics and Asians are disproportionately affected. ICH is fatal in 30 to 50% of all occurrences, while it leaves the majority of survivors with significant motor and cognitive disability.