Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III
Status:
Completed
Trial end date:
2016-01-01
Target enrollment:
Participant gender:
Summary
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).
Phase:
Phase 3
Details
Lead Sponsor:
Daniel Hanley Johns Hopkins University
Collaborators:
Emissary International LLC Genentech, Inc. National Institute of Neurological Disorders and Stroke (NINDS)