Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III

Conditions

Intraventricular Hemorrhage

What is the purpose of this trial?

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 and Boehringer Ingelheim, Inc., Ingelheim, Germany) 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).



Participation Guidelines

Age:
18 Years - 80 Years
Gender:
Both

Click here for detailed information about who can participate in this trial.


Sponsor:
Daniel Hanley
Emissary International LLC
Genentech, Inc.
National Institute of Neurological Disorders and Stroke (NINDS)
Dates:
July 2009
Last Updated:
September 18, 2014
Study HIC#:

Clinicaltrials.gov ID: NCT00784134