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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
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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: 18-80 • GCS<=14 or NHSS >=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
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
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 6 • 11.54 cc clot removed, 0h
Patient 6 • taken at 30h
Patient 6 • after 2 doses of rtPA