The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, is looking for individuals to participate in clinical studies. Participating in clinical trials allows you to play an active role in research on the nature and causes of many disorders of the brain and nervous system, and to possibly help physician-scientists develop future treatments. The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.


The purpose of this study is to test a minimally invasive surgical procedure with a drug called rt-PA (recombinant tissue plasminogen activator) as a treatment for intracerebral hemorrhage (ICH).

ICH occurs when a blood vessel in part of the brain bursts open, causing blood to leak into the brain and clot.  Currently, there is no standard treatment for ICH and most people with ICH face a long recovery and have long term deficits.

MISTIE III will test a minimally invasive surgical procedure in which a hollow tube, called a catheter, is used to remove the blood clot and administer rt-PA into the ICH to break up the blood clot.  Rt-PA is the standard treatment for ischemic stroke (a type of stroke in which a blood vessel is blocked by a clot).

Five hundred participants will be randomly assigned to one of two groups:  medical treatment or surgical treatment. In the medical group, participants will receive standard medical interventions for treating ICH. In the surgical group, participants will undergo a minimally invasive surgical procedure to put in place a catheter that will be used to administer rt-PA directly into the blood clot. After being assigned to a study group, participants will be monitored in the hospital for seven days. During this time, the medical group will receive the best currently available ICH treatments. The surgical group will receive up to 9 doses of rt-PA through the catheter every eight hours plus the same care the medical group receives. Both groups will have daily computed tomography (CT) brain scans.

Participants will be followed for a year after their ICH to determine if the surgical procedure and rt-PA will help them to recover more fully. Follow-up will include three outpatient visits to the clinic and two telephone interviews.

Knowledge gained from this study may provide scientists with information on how to better treat ICH.

Eligibility Criteria:


  • Age ≥ 18 and older.
  • Historical Rankin score of 0 or 1.
  • Spontaneous supratentorial ICH ≥ 30 mL diagnosed using radiographic imaging, with a Glasgow Coma Scale (GCS) ≤ 14 or a National Institutes of Health Stroke Scale (NIHSS) ≥ 6.
  • Six-hour clot size equal to the most previous clot size (within 5 mL) as determined by additional computed tomography (CT) scans at least 6 hours apart using the ABC/2 method.
  • Symptoms less than 24 hours prior to diagnostic CT scan.
  • Ability to randomize between 12 and 72 hours after diagnostic CT scan.
  • Systolic blood pressure < 180 mmHg sustained for six hours recorded closest to the time of randomization.


  • Allergy/sensitivity to rt-PA.
  • Known risk for embolization.
  • Intraventricular hemorrhage requiring treatment for IVH-related (casting) mass effect or shift due to trapped ventricle. EVD to treat ICP is allowed.
  • Infratentorial (brain area below the tentorium cerebelli) hemorrhage.
  • Thalamic bleeds with apparent midbrain extension with third nerve palsy or dilated and non-reactive pupils.
  • Irreversible impaired brain stem function, 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.
  • Persons with unstable mass or evolving intracranial compartment syndrome.
  • Platelet count < 100,000, International Normalized Ratio (INR) > 1.4.
  • Any irreversible coagulopathy or known clotting disorder.
  • Persons requiring long-term anti-coagulation.
  • Use of Dabigatran, Apixaban, and/or Rivaroxaban (or a similar medication from the similar medication class) prior to symptom onset.
  • Pregnancy.
  • Any concurrent serious illness that would interfere with the safety assessments.
  • Persons with a mechanical heart valve.
  • Active drug or alcohol use or dependence that would interfere with adherence to study requirements.
  • Persons who are unstable and would benefit from a specific intervention rather than supportive care plus or minus MIS+rt-PA removal of the ICH.

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Study Location:

Multiple U.S. Locations