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 III, 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, sold under the tradenames of Cathflo Activase by Genentech in the US and as Actilyse by Boehringer Ingelheim in Europe and Asia. 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 lead by Co-Principal Investigator Dr. Mario Zuccarello.
NIN/NINDS Cooperative Agreement: