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Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR III)



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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.

Description:

The purpose of the Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage III (CLEAR III) trial is to determine the benefit of using the clot-busting drug recombinant tissue plasminogen activator (t-PA) in conjunction with clot removal for the treatment of intraventricular hemorrhage (IVH).  IVH is sudden bleeding into the ventricular system of the brain, often the result of severe intracerebral hemorrhage (ICH).

The trial will compare extraventricular draining plus t-PA with extraventricular draining plus placebo (an inactive substance) in managing and treating individuals with small ICH and large IVH.  Extraventricular draining involves surgically inserting tubes that drain fluid from the brain’s ventricles.

Approximately 500 participants will be enrolled in the trial.  Participants will receive either t-PA or a placebo every 8 hours for up to 12 doses.  Symptom onset must be within 24 hours prior to a diagnostic computed tomography (CT) scan.  The neurological function of the 2 groups will be compared at multiple time points over the course of a year following treatment. Patient neurological status at 6 months is the primary outcome measurement.

Phase: 

Phase 3

Eligibility Criteria:

Inclusion:

  • Age 18-80
  • Symptom onset less than 24 hrs prior to diagnostic CT scan
  • Spontaneous ICH less than or equal to 30 cc or primary IVH
  • IVH obstructing 3rd and/or 4th ventricles
  • ICH clot stability at 6 hours or more post IVC placement
  • IVH clot stability at 6 hours or more post IVC placement
  • Catheter tract bleeding stability 6 hours or more post IVC placement
  • EVD placed per standard medical care
  • SBP less than 200 mmHg sustained for 6 hours prior to drug administration
  • No test article may be administered until at least 12 hours after symptom onset
  • Able to randomize within 72 hours of diagnostic CT scan
  • Historical Rankin of 0 or 1

Exclusion:

  • Suspected or untreated ruptured cerebral aneurysm, arteriovenous malformation (AVM), or tumor
  • Presence of a choroid plexus vascular malformation or Moyamoya
  • Clotting disorders. Subjects requiring long term anti-coagulation are excluded.
  • Use of Dabigitran prior to symptom onset.
  • Platelet count less than 100,000, international normalized ratio (INR) greater than 1.4
  • Pregnancy
  • Infratentorial hemorrhage
  • Thalamic bleeds with apparent midbrain extension with third nerve palsy or dilated and non-reactive pupils.
  • Subarachnoid hemorrhage (SAH) at clinical presentation
  • ICH/IVH enlargement that cannot be stabilized in the treatment time window
  • Ongoing internal bleeding
  • Superficial or surface bleeding
  • 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
  • Planned or simultaneous participation (between screening and Day-30) in another interventional medical investigation or clinical trial
  • No subject or legal representative to give written informed consent

Study Design: 

Interventional, Treatment

Study Locations: 

Multiple Locations Worldwide

For more information:

Contact: Karen Lane; telephone: 410-614-3461; email:klane@jhmi.edu; or the Brain Injury Outcomes main office: 410-614-6996

Visit: http://clinicaltrials.gov/ct2/show/NCT00784134 or www.braininjuryoutcomes.com

Last Reviewed February 10, 2014