Trial ID or NCT#

NCT00784134

Status

NOT RECRUITING

Purpose

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).

Official Title

Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III

Eligibility Criteria

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Chitra Venkatasubramanian, MBBS, MD
Neurocritical care specialist, Stroke and vascular neurologist
Clinical Professor, Neurology & Neurological Sciences
Neil Schwartz, MD, PhD
Stroke and vascular neurologist, Neurohospitalist, General neurologist
Clinical Professor, Neurology & Neurological Sciences Clinical Professor (By courtesy), Neurosurgery
Anna Finley Caulfield, MD
Neurocritical care specialist
Clinical Associate Professor, Neurology & Neurological Sciences
Gregory W. Albers, MD
Stroke and vascular neurologist
The Coyote Foundation Professor and Professor, by courtesy, of Neurosurgery at the Stanford University Medical Center
Maarten Lansberg, MD, PhD
Stroke and vascular neurologist, General neurologist
Associate Professor of Neurology
Marion S. Buckwalter, MD, PhD
Neurocritical care specialist
Associate Professor of Neurology and of Neurosurgery at the Stanford University Medical Center

Contact us to find out if this trial is right for you.

CONTACT

Christine Wijman
(650) 723-4448