Minimally Invasive Surgery and rtPA for Intracerebral Hemorrhage Evacuation
Condition: Intracerebral Hemorrhage
MeSH terms: Cerebral Hemorrhage; Hemorrhage
Intervention: MIS+Cathflo Activase (drug); Intraoperative stereotactic CT-Guided Endoscopic Surgery
Intervention description: MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.; Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative targeting arm as MISTIE arm. No rt-PA administered, and in addition to best medical care.
Intervention MeSH terms: Tissue Plasminogen Activator
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 141.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to determine the safety of using a combination of minimally
      invasive surgery and clot lysis with rt-PA to remove intracerebral hemorrhage (ICH). The ICES
      arm of the trial will determine the safety of endoscopic surgery to remove ICH. All MISTIE
      intention to treat subjects represent the hypothesized test group. The ICES cohort is to be
      analyzed separately.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-80

          -  GCS < 14 or a NIHSS > or equal to 6

          -  Spontaneous supratentorial ICH > or equal to 20cc

          -  Symptoms less than 12 hours prior to diagnostic CT scan (an unknown time of symptom
             onset is exclusionary)

          -  Intention to initiate surgery within 48 hours after diagnostic CT

          -  First dose can be given within 54 hours after diagnostic CT (delays for post surgical
             stabilization of catheter bleeding or because of unanticipated surgical delay are
             acceptable with approved waiver from the coordinating center) (Does not apply to ICES
             Tier)

          -  Six-hour clot size equal to the most previous clot size + 5 cc (as determined by an
             additional CT scan at least 6 hours after the initial stability scan (A*B*C)/2 method)

          -  SBP < 200 mmHg sustained for 6 hours recorded closest to time of randomization

          -  Historical Rankin score of 0 or 1

          -  Negative pregnancy test

        Exclusion Criteria:

          -  Infratentorial hemorrhage (any involvement of the midbrain or lower brainstem as
             demonstrated by radiograph or complete third nerve palsy)

          -  Patients with platelet count < 100,000, INR > 1.4, or an elevated PT or APTT (reversal
             of coumadin is permitted but the patient must not require coumadin during the acute
             hospitalization). Irreversible coagulopathy either due to medical condition or prior
             to randomization

          -  Clotting disorders

          -  Any concurrent serious illness that would interfere with the safety assessments
             including hepatic, renal, gastroenterologic, respiratory, cardiovascular,
             endocrinologic, immunologic, and hematologic disease

          -  Patients with a mechanical valve

          -  Patients with unstable mass or evolving intracranial compartment syndrome

          -  Ruptured aneurysm, AVM, vascular anomaly

          -  Greater than 80 years (higher incidence of amyloid)

          -  Under 18 years of ag e (high incidence of occult vascular malformation)

          -  Pregnant (positive pregnancy test) or lactating females (likelihood of altered
             coagulation function associated with the high estrogen/progesterone state)

          -  Irreversibly impaired brainstem function (bilateral fixed, dilated pupils and extensor
             motor posturing), GCS less than or equal to 4

          -  Historical Rankin score greater than or equal to 2

          -  Intraventricular hemorrhage requiring external ventricular drainage

          -  Internal bleeding, involving retroperitoneal sites, or the gastrointestinal,
             genitourinary, or respiratory tracts (Does not apply to ICES Tier)

          -  Superficial or surface bleeding, observed mainly at vascular puncture and access sites
             (e.g., venous cutdowns, arterial punctures) or site of recent surgical intervention
             (Does not apply to ICES Tier)

          -  Known risk for embolization, including history of left heart thrombus, mitral stenosis
             with atrial fibrillation, acute pericarditis, and subacute bacterial endocarditis
             (Does not apply to ICES Tier)

          -  In the investigator's opinion, the patient is unstable and would benefit from a
             specific intervention rather than supportive care plus or minus MIS+rtPA

          -  Prior enrollment in the study

          -  Any other condition that the investigator believes would pose a significant hazard to
             the subject if the investigational therapy were initiated

          -  Participation in another simultaneous trial of ICH treatment.