Preliminary Findings of the Minimally-Invasive Surgery Plus rtPA for Intracerebral Hemorrhage Evacua...
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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


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


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


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