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Clinical Trial Title: 
A phase III, randomized, case-controlled, open-label, 500-subject clinical trial of minimally invasive surgery plus rt-PA in the treatment of intracerebral hemorrhage (ICH).
Clinical Trial Protocol ID: 
Clinical Trial Investigator Name: 
George Lopez, MD, PhD
Clinical Trial Protocol Description: 

Primary objective: Demonstrate that minimally invasive surgery (MIS) plus recombinant tissue plasminogen activator (rt-PA) for three days improves functional outcome by a 12% increase in the modified Rankin Scale (mRS) score 0-3 compared to medically treated subjects assessed at 180 days.

Secondary Objective: Demonstrate that the end of treatment volume and percent of ICH reduction from MIS+rt-PA is related to improved functional outcome, as compared to medically treated subjects.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have spontaneous supratentorial ICH ≥ 30 mL diagnosed using radiographic imaging (CT, CTA, etc.), with a GCS ≤ 14 or a NIHSS ≥ 6.
  • Have 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.
  • Have symptoms less than 24 hours prior to diagnostic CT (dCT) scan (an unknown time of onset is exclusionary).
  • Have ability to randomize between 12 and 72 hours after dCT.
  • Have SBP < 180 mmHg sustained for six hours recorded closest to the time of randomization.
  • Have a historical Rankin score of 0 or 1.
  • Are age ≥ 18 and older.

You will be excluded from the study if any of the following criteria apply to you:

  • Have infratentorial hemorrhage.
  • Have intraventricular hemorrhage requiring treatment for IVH-related (casting) mass effect or shift due to trapped ventricle. EVD to treat ICP is allowed.
  • Have 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.
  • Have irreversible impaired brain stem function (bilateral fixed, dilated pupils and extensor motor posturing), GCS ≤ 4.
  • Have 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.
  • Have unstable mass or evolving intracranial compartment syndrome.
  • Have platelet count < 100,000, INR > 1.4, or an elevated prothrombin time (PT) or activated partial thromboplastin time (aPTT).
  • Have any irreversible coagulopathy or known clotting disorder.
  • Are not able to sustain INR ≤ 1.4 using short- and long-active procoagulants (such as but not limited to NovoSeven, FFP, and/or vitamin K).
  • Require long-term anti-coagulation. 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 instrumentation.
  • Use of Dabigatran, Apixaban, and/or Rivaroxaban (or a similar medication from the similar medication class) prior to symptom onset.
  • Have internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts.
  • Have superficial or surface bleeding, observed mainly at vascular puncture and access sites (e.g., venous cutdowns, arterial punctures, etc.) or site of recent surgical intervention.
    Have positive urine or serum pregnancy test in pre-menopausal female subjects without a documented history of surgical sterilization.
  • Have a mechanical heart valve. Presence of bio-prosthetic valve(s) is permitted.
  • Have a known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Stroke and Cerebrovascular Disease
Contact Phone: 
(312) 942-6731
Contact Name: 
Rebecca Holtz