MISTIE III: A phase III, randomized, open-label, 500-subject clinical trial of minimally invasive surgery plus rt-PA in the treatment of intracerebral hemorrhage.
This study is a phase iii, randomized, open-label, multicenter evaluation of MiS and iCH
lysis with rt-Pa versus medical care. The study (n[?]500) will evaluate the efficacy and
safety of MiS plus 1 mg of rt-Pa administered every eight hours for up to nine doses as
compared to subjects treated with conventional medical management. endpoint
assessment will be performed by blinded investigators.
interventions and Duration
The study is proposed to require five years. all subjects will be followed daily for six
days post randomization. Subjects randomized to receive the surgical intervention will
undergo aspiration of clot followed by up to nine drug administrations. all subjects will
be required to attend follow-up clinic visits at 30, 180, and 365 days after onset of iCH. a
telephone follow-up will occur at 90 and 270 days.
Sample Size and Population
The study population will include 500 subjects adaptively randomized 1:1 across
approximately 90 to 100 study centers with supratentorial iCH without suspected
underlying structural etiology (tumor, vascular malformation or aneurysm). Subjects will
be identified and recruited through the emergency Department, clinical stroke service,
and direct admissions to the neurocritical Care unit at each study center.
* Spontaneous supratentorial ICH >= 30 mL measured by the site utilizing ABC/2
method using radiographic imaging (CT, CTA, etc.), with a GCS <= 14 or a NIHSS
* Stability CT scan done at least 6 hours after diagnostic CT showing clot stability
(growth < 5 mL as measured by ABC/2 method).
If the clot volume measured on this stability CT scan increases by 5 mL or
more, a second stability determination is allowed by repeat CT scan at least 12
hours later. Additional scans are permitted as needed every 12 hours to continue
to monitor for stability up until the eligibility time window closes. Subsequent
clot retraction remains inclusionary as long as the ICH clot size remains >= 25 mL.
* Symptoms less than 24 hours prior to diagnostic CT (dCT) scan. An unknown
time of onset is exclusionary. Use the time the patient was last known to be well
for patients that awaken from sleep with symptoms.
* Ability to randomize between 12 and 72 hours after dCT.
* SBP < 180 mmHg sustained for six hours recorded closest to the time of
* Historical Rankin score of 0 or 1.
* Age >= 18 and <= 80.