Preliminary Findings of the Minimally- Invasive Surgery Plus rtPA for Intracerebral Hemorrhage Evacuation (MISTIE) Clinical Trial T. Morgan, M. Zuccarello, R. Narayan, P. Keyl, K. Lane, D. Hanley Journal Club Presentation: Alvin P. Penalosa, MD Neurosurgery Senior House Officer Newcastle General Hospital

Intracerebral Hemorrhage 15-30% of strokes in the UK, but the most deadly smaller bleeds (<20cc) lower mortality and better outcome Current standard: medical treatment, craniotomy in the most severe cases.

Objective To determine the safety of using a combination of minimally invasive surgery and clot lysis with rt-PA to remove intracerebral hemorrhage (ICH) to test the safety of this intervention assess ability of this technique to remove blood clot from brain tissue

Background Trial Phase:Phase II Study Size Actual:54 Study Size Planned:110 Centers Actual:22 Max Time from onset:12 Hours Age:18-80 Follow-up Duration:180 Days

Primary Endpoints 30-day mortality procedure related mortality incidence of cerebritis, meningitis rate of rebleeding

Secondary Endpoints Rate of clot size reduction at Days 4-5 determined by CT scans 90 & 180 day GOS, Rankin, Stroke Impact Scale

Inclusion Criteria Age: GCS =6 CT: ICH>=25cc shown to be stable at least 6h later via 2nd CT historic Rankin score of 0 or 1 not pregnant

Exclusion Criteria any infratentorial hemorrhage IVH requiring EVD coagulopathy vascular abnormality proven by MRA or CTA

Methodology

14-French cannula steriotactically placed in center of the parenchymal clot 2/3 the length of long axis and within the middle 1/3 of the clot aspiration using 10cc syringe until first resistance to free hand suction soft ventriculostomy catheter is passed through the rigid cannula remove rigid cannula

CT: position, rebleed 0.3mg rtPA followed by sterile flush; close system for 1 hour repeat every 8hours for a total of 9 doses or until a clinical endpoint is reached

Clinical Endpoints reduction of clot to 80% of original size clot size reduced to 15cc or less any bleeding events or new hemorrhage extension of hemorrhage by 5cc or more

Results

Treatment Starting Volume Post-Surgery Volume End-of- Treatment Volume 7-day follow- up Volume Surgery+rTP A n= Medical n= N/A 36.65

Summary of Results Aspiration alone: 20% (n=4) After treatment: 50% of starting volume vs 6% reduction (medical management) O doses=4, 9 doses=3 8% symptomatic rebleed bacterial ventriculitis= 0%

Patient 5 Medical Management (0h, 38.5h, 81h)

Patient cc clot removed, 0h

Patient 6 taken at 30h

Patient 6 after 2 doses of rtPA