CLEAR INTRAVENTRICULAR HEMORRHAGE TRIAL

Does faster clot removal give better patient outcomes in IVH?

24-hour BIOS Cell Phone:  (410) 736-1368 (pre-randomization medical review)

24-hour Surgical Center Pager:  (773)-845-6145 (pre-randomization surgical review)

VISION EDC (case form) Website: http://bios.preludedynamics.com/vision

NIHSS/mRS Certification Courses:  http://clear-3.trainingcampus.net (requires separate log-in)

 

Protocol Title:  Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage, Phase III (CLEAR III)

Protocol Number:  IVH06

Current Version:  Version 3.0 / Last Revised 22-Mar-2011

  

Study Drug:  Alteplase® (recombinant tissue plasminogen activator), donated by Genentech Inc.

Study Design: multicenter, international, double-blind, placebo-controlled, randomized, parallel group

Primary Aim: determine if rapid removal of IVH clot with low-dose rtPA improves Modified Rankin Scores (0-3) at 6 Months as compared to subjects treated with best medical care alone

 

FDA IND Number:  BB-IND# 8523, submitted 28-July-1999

Sponsor: Daniel F. Hanley, MD (Head of Brain Injury Outcomes at Johns Hopkins)

Primary Funding: National Institute of Neurologic Disorders & Stroke (NINDS), an NIH institute (Collaborative Grant)

 

Target Enrollment:  500 patients (250 in each arm)

First Patient:  20-September, 2009  

Expected Completion:  Dec-2014 (for last enrollment), Dec-2015 (for last-patient-last visit)

Sites:  Approximately 70 across US, Canada, UK, Germany, Hungary, Brazil, Israel

 

NCT Registration Number:  NCT00784134

 

CLEAR Study App:  Android, Apple iOS 

 

 

Brain Injury Outcomes

Johns Hopkins University
1550 Orleans Street
CRB-II, 3M50 South
Baltimore, MD 21231 USA
Office:   (410) 614-6996
Fax: (410) 502-7869
 
24-Hr: (410) 736-1368