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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 - 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, MDNeurosurgery 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.
ObjectiveTo 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
BackgroundTrial 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 Endpoints30-day mortality
procedure related mortality
incidence of cerebritis, meningitis
rate of rebleeding
Secondary EndpointsRate of clot size reduction at Days 4-5 determined by CT scans
90 & 180 day GOS, Rankin, Stroke Impact Scale
Inclusion CriteriaAge: 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 Criteriaany 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 Endpointsreduction 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
TreatmentTreatment Starting Starting VolumeVolume
Post-Post-Surgery Surgery VolumeVolume
End-of-End-of-TreatmentTreatment
VolumeVolume
7-day 7-day follow-up follow-up VolumeVolume
Surgery+rTPA
n=1948.07 37.02 25.21 19.37
Medicaln=2
38.97 N/A N/A 36.65
Summary of ResultsAspiration 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 611.54 cc clot removed, 0h
Patient 6taken at 30h
Patient 6after 2 doses of rtPA
Recommended