Intraventricular hemorrhage (IVH) is sudden bleeding into the ventricular system of the brain, often the result of severe ICH. This complication of hemorrhagic stroke has a mortality rate of 60-80%, and only about 10% of patients recover with a good outcome.
CLEAR III is a 500-patient phase 3 randomized clinical trial using a recombinant tissue plasminogen activator (Activase) to quickly remove this blood from the ventricles. It is the hope of the over 70 academic medical centers in this international clinical trial that this may prove to be a better way to treat this brain injury.
The primary aim of the study is to determine whether rapid removal of IVH with low-dose TPA improves modified Rankin Scale scores over 12 months (a measure of neurologic status) compared to subjects treated with best medical care alone. Earlier studies have shown that placing a small catheter into the ventricle and giving a series of doses of TPA through it can remove most of the blood within a few days. Although it seems logical and early results have been promising, physicians still do not definitively know if removing the blood quickly (as compared to the slow healing process that naturally occurs over a period of weeks to months in patients that initially survive the stroke) will result in a better outcome for the patient 6-12 months later. If this therapy can reduce the rate of death and improve the quality of life for these patients, it could significantly change the way intraventricular hemorrhage is treated around the world.
CLEAR III is the culmination of 10 years of research over a number of investigational trials. The early clinical studies were supported by grants from the Food and Drug Administration (FDA) Office of Orphan Products Development, the American Heart Association and other organizations. Funding for CLEAR III is supported by grants from the National Institute of Neurological Disorders and Stroke (NINDS) and from the Eleanor Naylor Dana Charitable Trust, the Jeffrey and Harriet Legum Endowment, and support from Genentech, Inc. Over 70 major hospitals and academic institutions are participating in this trial as clinical sites or support teams.
NIH/NINDS Cooperative Agreement: U01 NS062851-02
ClinicalTrials.gov Identifier: NCT00784134
To request CLEAR III data: BIOS Data Request Form