After a tremendous effort over several months by all of the staff at the Johns Hopkins BIOS (Brain Injury Outcomes) coordinating center as well as the coordinators and investigators at over 35 investigational sites, we are happy to announce that a grant application has been submitted to the National Institute of Neurological Disorders and Stroke (NINDS, part of the National Institute of Health or NIH) requesting funding for the next phase in the MISTIE clinical development program.
If approved by NINDS, MISTIE III will be a phase III, 500-patient, multicenter, international clinical trial to assess the efficacy and safety of using minimally-invasive surgery (MIS, basically inserting a small catheter into the brain) and a thrombolytic drug (tissue plasminogen activator or tPA, administered via this catheter) to rapidly reduce the size of an intracerebral hematoma (ICH, a blood clot in the brain). The goal will be to determine with statistical power if this rapid reduction of the ICH using the MIS+tPA approach definitively leads to reduced mortality/morbidity and improved functional outcomes (better quality of life, better physical and mental function) compared to standard medical care alone. Preliminary data from the MISTIE phase II trial which recently completed enrollment has given a strong signal that the MISTIE treatment, by shortening the duration of physical and biochemical injury to the brain caused by the hematoma, is beneficial to the patient. In statistical terms, MISTIE II has shown that, when surgeons reduce the clot to under 15cc over a 1-3 day period using this approach, the odds for benefit, as measured by dichotomized Modified Rankin Scale (0-3), are 3.6 times better (p=0.053).
If this clinical improvement can be validated in this MISTIE III trial, it will undoubtedly lead to a major change in the way ICH is treated throughout the world. Currently, there is no proven alternative treatment for ICH (other than just intensive ICU care) and an unacceptably high percentage of ICH patients die or end up with major mental and physical handicap. For medical researchers like us, this is the kind of effort that you want to tell your grandchildren that you were part of, a chance to possibly change the way medicine is practiced around the world and potentially improve the hundreds of thousands of thousands of people who suffer after a hemorrhagic stroke.
Hopefully, NINDS will approve the funding and the trial will begin shortly thereafter. As we gear-up for this trial, we will post further details here on this website. Meanwhile, the anxious waiting begins.