all trials & studies

Study Name: "Spot Sign" Selection of Intracerebral Hemorrhage to Guide Hemostatic Therapy (SPOTLIGHT) 
Principal Investigator: David J Gladstone, MD
Coordinating Center: University of Calgary, Canada
Research Plan: This phase II double blind RCT will enroll 110 patients from approximately 15 Canadian stroke centres. Acute ICH patients who can be treated within 6 hours of onset will undergo CT angiography using standard CT procedures. Those with a spot sign will be randomly assigned in a 1:1 ratio to a single injection of rFVIIa 80 μg/kg or placebo; patients without a spot sign will not be treated. The primary endpoint is ICH expansion within 24 hours.
Target Enrollment: 110
Number of Study Sites: 15
Start Date: May 1, 2011
Anticipated Stop Date: Aug. 1, 2016
Funding Source: Sunnybrook Health Sciences Centre
Contact Information: David J Gladstone, MD; 403-944-8287; 
NCT Number: NCT01359202

Study Name: Clot Lysis Evaluating Accelerated Resolution of Intraventricular Hemorrhage-III (CLEAR-IVH III)

Principal Investigator: Daniel Hanley, Issam Awad
Coordinating Center: The Johns Hopkins University
Research Plan: CLEAR-IVH III is a study of intraventricular tPA for clearance of intraventricular hemorrhage (IVH). Patients with intraventricular hemorrhage (IVH) who have undergone placement of an external ventricular drain (EVD) will be enrolled. Clot size must be stable for at least 6 hours and tPA must be administered within 48 hours of onset. Placebo or 1 mg of tPA is administered via every 8 hours for up to 96 hours (12 doses) or clearance of IVH. The primary endpoint is 6-month modified Rankin scale score. Secondary endpoints include multiple functional outcome assessment scales, mortality, duration of ventricular drainage, and interval to clot resolution.
Target Enrollment: 500
Number of Study Sites: 70
Start Date: Fall 2008
Anticipated Stop Date: 2015 Funding Source: NINDS
Contact Information: 
NCT Number: N/A