Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III
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).
- 18 Years - 80 Years
- Daniel Hanley
Emissary International LLC
National Institute of Neurological Disorders and Stroke (NINDS)
- July 2009
- Last Updated:
- September 18, 2014
- Study HIC#:
Clinicaltrials.gov ID: NCT00784134