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BATTLE OF NEW ORLEANS 2013

A Dedication to Dan Hanley and the CLEAR and MISTIE Project Teams

Composed and sung in Waikiki on 05-February-2013 by Keith Gregson while attending the International Stroke Conference. It is set to an old cajun fiddle tune and dedicated to Dan Hanley and members of the CLEAR and MISTIE teams at JHU, Baltimore, Maryland. Keith is the spouse of Barbara Gregson, who manages the STICH-II trial and is a member of the CLEAR steering committee.

In 2013 we took a little trip to a famous city on the mighty Mississip
To watch Ray Lewis and his Superbowl machine meet the 49ers in the ‘town’ of New Orleans

Dr. Daniel Hanley, co-principal investigator for the MISTIE clinical trial, was a featured speaker this week at the 2013 International Stroke conference (ISC) in Honolulu as he presented 365-day results from this phase-II clinical trial. MISTIE is an acronym for Minimally Invasive Surgery + rt-PA for Intracerebral Hemorrhage (ICH) Evacuation. ICH is a type of stroke caused by bleeding within the brain, often the result of uncontrolled hypertension. It is also referred to as cerebral stroke or hemorrhagic stroke.

This recently-completed proof-of-concept trial evaluated the use of tPA (a thrombolytic or clot-busting drug) delivered via a catheter placed under CT (a series of x-ray images) guidance. Data from the 123 patients enrolled across 26 medical centers provides ground-breaking evidence, which now needs to be verified in a larger phase-III trial, that this technique offers future promise for reducing the high rate of death and serious disability in ICH patients. Preliminary results were presented at last year's conference. Now that study participants have reached the one-year mark, the final results are even more encouraging. A summary of these results have been published on the American Stroke Society's ISC website -- scroll to the bottom to see Dr. Hanley's late-breaking presentation materials.

The last patient has now completed in Stage II of the phase II MISTIE trial and the final patient in the endoscopy tier should reach the one-year follow-up endpoint next spring. We now turn to data analysis and publication of final results in this trial of minimally-invasive approaches to intracerebral hemorrhage (ICH). Meanwhile, we are already on the road to a phase III trial!

The Data Safety Monitoring Board (DSMB) for the CLEAR-III clinical trial met today to review detailed data on the first 175 patients in the trial (152 post Day-180), with additional preliminary data from a total of 251 enrolled patients from across 61 clinical sites. CLEAR-III is a phase III clinical efficacy and outcomes study assessing the effect of external ventricular drainage (EVD) with rt-PA or placebo to treat intraventricular hemorrhage (IVH). The first subject, out of a planned 500, was enrolled in September 2009.