Minimally Invasive Surgery and rtPA for Intracerebral Hemorrhage Evacuation

PHASE2CompletedINTERVENTIONAL
Enrollment

141

Participants

Timeline

Start Date

August 31, 2005

Primary Completion Date

August 31, 2012

Study Completion Date

April 30, 2013

Conditions
Intracerebral Hemorrhage
Interventions
DRUG

MIS+Cathflo Activase (drug)

MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.

PROCEDURE

Intraoperative stereotactic CT-Guided Endoscopic Surgery

Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative targeting arm as MISTIE arm. No rt-PA administered, and in addition to best medical care.

Trial Locations (29)

10029

Mt. Sinai Medical Center, New York

15212

Allegheny General Hospital, Pittsburgh

15213

University of Pittsburgh Medical Center, Pittsburgh

19107

Thomas Jefferson University, Philadelphia

19140

Temple University, Philadelphia

20007

Georgetown University, Washington D.C.

21201

University of Maryland Medical Systems, Baltimore

21287

Johns Hopkins University/Bayview Medical Center, Baltimore

23298

Virginia Commonwealth University, Richmond

29425

Medical University of South Carolina, Charleston

32216

Mayo Clinic, Jacksonville

35294

University of Alabama at Birmingham, Birmingham

44106

Case Western University, Cleveland

45267

University of Cincinnati, Cincinnati

48202

Henry Ford Health System, Detroit

60201

NorthShore University Health System, Evanston

60612

Rush University, Chicago

60637

University of Chicago, Chicago

69117

University of Heidelberg, Heidelberg

77030

University of Texas, Houston, Houston

78229

University of Texas HSC, San Antonio, San Antonio

85013

Barrow Neurosurgical Associates, Phoenix

90095

University of California Los Angeles, Los Angeles

92103

University of California, San Diego, San Diego

94034

Stanford University, Palo Alto

06102

Hartford Hospital, Hartford

08818

JFK Medical Center New Jersey, Edison

H3A 2B4

Montreal Neurological Institute at McGill University, Montreal

Unknown

Newcastle General Hospital, Newcastle

All Listed Sponsors
collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

collaborator

Genentech, Inc.

INDUSTRY

collaborator

Emissary International LLC

INDUSTRY

lead

Daniel Hanley

OTHER