MISTIE: Minimally Invasive (Stereotactic) Surgery + rt-PA for ICH Extraction

Intracerebral hemorrhage accounts for 10-20% of the 500,000 stokes per year in the United States. Unfortunately, the incidence of ICH has not decreased over the last 2 decades and the mortality rate in these cases ranges from 40-60%. This mortality rate is up to six times higher than that for ischemic stroke. Level of consciousness on admission and size of hematoma repeatedly correlate with the outcome in ICH. In an attempt to improve upon the dismal outcome many neurosurgeons have operated to evacuate or at least decrease the size of the hematomas. Unfortunately the early results were not shown to be beneficial and the option of medical versus surgical therapy remains controversial. While it still remains unclear as to overall benefit of surgery in relation to lesion location , what is clear from the literature is that surgery is definitely not helpful in improving outcome in patients with hematoma >9-10 cm in volume regardless of location.

This study is a multicenter evaluation of minimally invasive surgery and ICH lysis with rt PA. The dose finding stage (n=60) will evaluate the safety of minimally invasive surgery plus three successive doses of rt PA, 0.3, 1.0, or 3.0 mg, administered every 8 hrs for up to 72 hrs. The safety study stage (n=50) will compare minimally invasive surgery plus the optimal dose from the dose finding stage with conventional medical management.

Screening procedures at Mount Sinai Medical Center (MSMC) started on 5/11/2006. In 2006, three patients were enrolled. All three were followed after discharge from MSMC until the 180 day follow up visit. One patient was able to return home directly from the MSMC acute rehabilitation unit, the other two were discharged to sub-acute facilities. One of those was about to be discharged to home at last contact.

In total, 85 patients have been screened at MSMC through December, 2007. No eligible patients were screened in 2007.

Total enrollment at other sites is 23 patients.The NIH Program Officer approved JH’s request for study center expansion. Four additional sites have been activated: St. Louis University, Loyola University Medical Center, Stanford University, and Montreal Neurological Institute at McGill University. They are currently working with ten other interested sites in order to get them ready for site activation.