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