Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III

Completed · Phase 3 · Has a placebo group

Conditions studied: Intraventricular Hemorrhage

In brief

The overall objective of this Phase III clinical trial is to obtain information from a population of 500 ICH subjects with intraventricular hemorrhage (IVH), representative of current clinical practice and national demographics of ICH regarding the benefit (or lack thereof) of IVH clot removal on subject function as measured by modified Rankin Scale (mRS). This application requests funding for five years to initiate a Phase III randomized clinical trial (RCT) testing the benefit of clot removal for intraventricular hemorrhage. The investigators propose to compare extraventricular drainage (EVD) use plus recombinant tissue plasminogen activator (rt-PA; Alteplase; Genentech, Inc., San Francisco, CA) with EVD+ placebo in the management and treatment of subjects with small intracerebral hemorrhage (ICH) and large intraventricular hemorrhage (IVH defined as ICH \< 30 cc and obstruction of the 3rd or 4th ventricles by intraventricular blood clot).

Key facts

Study ID

NCT00784134

Run by

Johns Hopkins University

People needed

500

Starts

2009-07-01

Expected to finish

2016-01-01

Last updated by the study team

2018-12-05

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Able to randomize within 72 hours of diagnostic CT scan
• Historical Rankin of 0 or 1

You may not qualify if…

• Suspected or untreated ruptured cerebral aneurysm, AVM, or tumor
• Presence of a choroid plexus vascular malformation or Moyamoya
• Clotting disorders
• Platelet count less than 100,000, INR greater than 1.4
• Pregnancy
• Infratentorial 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

Where it is running

• Mayo Clinic, Arizona — Phoenix, Arizona, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of Southern California - Keck School of Medicine — Los Angeles, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• Stanford University — Palo Alto, California, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• Mayo Clinic, Jacksonville — Jacksonville, Florida, United States
• Intercoastal Medical Center — Sarasota, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Rush University — Chicago, Illinois, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Ruan Neurology Clinical and Research Center — Des Moines, Iowa, United States
• University of Iowa — Iowa City, Iowa, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• University of Maryland — Baltimore, Maryland, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Henry Ford Health System — Detroit, Michigan, United States
• St. Luke's Brain and Stroke Institute — Kansas City, Missouri, United States
• Springfield Neurological and Spine Institute — Springfield, Missouri, United States
• St. Louis University — St Louis, Missouri, United States
• Cooper University Hospital — Camden, New Jersey, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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