NCT00784134

Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Intraventricular Hemorrhage

Interventions

Type	Name	Description
DRUG	Alteplase	1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses
OTHER	Normal saline	1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses

Timeline

• Start date: 2009-07-01
• Primary completion: 2015-07-01
• Completion: 2016-01-01
• First posted: 2008-11-03
• Last updated: 2018-12-05
• Results posted: 2017-07-02

Locations

81 sites across 9 countries: United States, Brazil, Canada, Germany, Hungary, Israel, Spain, Switzerland, United Kingdom