Conditions: Intraventricular Hemorrhage
Keywords: intraventricular hemorrhage thrombolysis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 500
Healthy volunteers: no

Brief 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).

Detailed description:

Arms:
arm 1: administration of alteplase via the intraventricular catheter arm 2: 1 ml of normal saline administered via the intraventricular catheter

Interventions: intervention 1: Alteplase intervention 2: Normal saline
Intervention descriptions: intervention 1: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses intervention 2: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses

Protocol document: