Last updated on August 2018

Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation Phase III

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cerebral Hemorrhage
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other:
    Spontaneous supratentorial ICH ≥ 30 mL diagnosed using radiographic imaging
    (computerized tomography (CT), computerized tomography angiography (CTA), etc.), with
    a Glasgow Coma Scale (GCS) ≤ 14 or a NIHSS ≥ 6.
    Six-hour clot size equal to the most previous clot size (within 5 mL) as determined
    by additional CT scans at least 6 hours apart using the ABC/2 method.
    Symptoms less than 24 hours prior to diagnostic CT (dCT) scan (an unknown time of
    onset is exclusionary).
    Ability to randomize between 12 and 72 hours after dCT.
    Systolic Blood Pressure (SBP) < 180 mmHg sustained for six hours recorded closest to
    the time of randomization.
    Historical Rankin score of 0 or 1.
    Age ≥ 18 and older.

You may not be eligible for this study if the following are true:

  • Infratentorial hemorrhage.
    Intraventricular hemorrhage (IVH) requiring treatment for IVH-related (casting) mass
    effect or shift due to trapped ventricle. External ventricular drain (EVD) to treat
    intracranial pressure (ICP) is allowed.
    Thalamic bleeds with apparent midbrain extension with third nerve palsy or dilated
    and non-reactive pupils. Other (supranuclear) gaze abnormalities are not exclusions.
    Note: Patients with a posterior fossa ICH or cerebellar hematomas are ineligible.
    Irreversible impaired brain stem function (bilateral fixed, dilated pupils and
    extensor motor posturing), GCS ≤ 4.
    Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya
    disease, hemorrhagic conversion of an ischemic infarct, recurrence of a recent (< 1
    year) hemorrhage diagnosed with radiographic imaging.
    Patients with unstable mass or evolving intracranial compartment syndrome.
    Platelet count < 100,000, international normalized ratio (INR) > 1.4, or an elevated
    prothrombin time (PT) or activated partial thromboplastin time (aPTT).
    Any irreversible coagulopathy or known clotting disorder.
    Inability to sustain INR ≤ 1.4 using short- and long-active procoagulants (such as
    but not limited to NovoSeven, Fresh Frozen Plasma (FFP), and/or vitamin K).
    Subjects requiring long-term anti-coagulation are excluded. Reversal of
    anti-coagulation is permitted for medically stable patients who can realistically
    tolerate the short term risk of reversal. Patient must not require Coumadin
    (anticoagulation) during the first 30 days, and normalized coagulation parameters
    must be demonstrated, monitored closely and maintained during the period of brain
    Use of Dabigatran, Apixaban, and/or Rivaroxaban (or a similar medication from the
    imilar medication class) prior to symptom onset.
    Internal bleeding, involving retroperitoneal sites, or the gastrointestinal,
    genitourinary, or respiratory tracts.
    Superficial or surface bleeding, observed mainly at vascular puncture and access
    ites (e.g., venous cutdowns, arterial punctures, etc.) or site of recent surgical
    Positive urine or serum pregnancy test in pre-menopausal female subjects without a
    documented history of surgical sterilization.
    Allergy/sensitivity to rt-PA.
    Prior enrollment in the study.
    Participation in a concurrent interventional medical investigation or clinical trial.
    Patients in observational, natural history, and/or epidemiological studies not
    involving an intervention are eligible.
    Not expected to survive to the day 365 visit due to co-morbidities and/or are do not
    resuscitate (DNR)/ do not intubate (DNI) status prior to randomization.
    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 heart valve. Presence of bio-prosthetic valve(s) is
    Known risk for embolization, including history of left heart thrombus, mitral
    tenosis with atrial fibrillation, acute pericarditis, or subacute bacterial
    Any other condition that the investigator believes would pose a significant hazard to
    the subject if the investigational therapy were initiated.
    Active drug or alcohol use or dependence that, in the opinion of the site
    investigator, would interfere with adherence to study requirements.
    In the investigator's opinion, the patient is unstable and would benefit from a
    pecific intervention rather than supportive care plus or minus MIS+rt-PA removal of
    the ICH.
    Inability or unwillingness of subject or legal guardian/representative to give
    written informed consent.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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