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T. Morgan, M. Zuccarello, R. Narayan, P. Keyl, K. Lane, D. Hanley Journal Club Presentation: - PowerPoint PPT Presentation


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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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slide1
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
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
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
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
Primary Endpoints
  • 30-day mortality
  • procedure related mortality
  • incidence of cerebritis, meningitis
  • rate of rebleeding
secondary endpoints
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
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
Exclusion Criteria
  • any infratentorial hemorrhage
  • IVH requiring EVD
  • coagulopathy
  • vascular abnormality proven by MRA or CTA
slide12
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
slide13
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
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
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
Patient 5
  • Medical Management (0h, 38.5h, 81h)
patient 6
Patient 6
  • 11.54 cc clot removed, 0h
patient 61
Patient 6
  • taken at 30h
patient 62
Patient 6
  • after 2 doses of rtPA
ad