The purpose of this trial is to determine the safety of using a combination of minimally
invasive surgery and clot lysis with rt-PA to remove intracerebral hemorrhage (ICH). The
procedure is to use image-based surgery (MRI or CT) to provide catheter access to ICH for
the intervention, which is a one-time clot aspiration followed by instillation of rt-PA over
72 hours. We propose to test if this intervention facilitates more rapid and complete
recovery of function and decreased mortality from this condition compared to conventional
medical management without subjecting the patient to craniotomy. The specific objective of
this trial is to test the safety of this intervention and assess its ability to remove blood
clot from brain tissue.
Inclusion Criteria:
- Age 18-80
- GCS < 14 or a NIHSS > or equal to 6
- Spontaneous supratentorial ICH > or equal to 20cc
- Symptoms less than 12 hours prior to diagnostic CT scan (an unknown time of symptom
onset is exclusionary)
- Intention to initiate surgery within 48 hours after diagnostic CT
- First dose can be given within 54 hours after diagnostic CT (delays for post
surgical stabilization of catheter bleeding or because of unanticipated surgical
delay are acceptable with approved waiver from the coordinating center)
- Six-hour clot size equal to the most previous clot size + 5 cc (as determined by an
additional CT scan at least 6 hours after the initial stability scan (A*B*C)/2
method)
- SBP < 200 mmHg sustained for 6 hours recorded closest to time of randomization
- Historical Rankin score of 0 or 1
- Negative pregnancy test
Exclusion Criteria:
- Infratentorial hemorrhage (any involvement of the midbrain or lower brainstem as
demonstrated by radiograph or complete third nerve palsy)
- Patients with platelet count < 100,000, INR > 1. 4, or an elevated PT or APTT
(reversal of coumadin is permitted but the patient must not require coumadin during
the acute hospitalization). Irreversible coagulopathy either due to medical
condition or prior to randomization
- Clotting disorders
- Any concurrent serious illness that would interfere with the safety assessments
including hepatic, renal, gastroenterologic, respiratory, cardiovascular,
endocrinologic, immunologic, and hematologic disease
- Patients with a mechanical valve
- Patients with unstable mass or evolving intracranial compartment syndrome
- Ruptured aneurysm, AVM, vascular anomaly
- Greater than 80 years (higher incidence of amyloid)
- Under 18 years of ag e (high incidence of occult vascular malformation)
- Pregnant (positive pregnancy test) or lactating females (likelihood of altered
coagulation function associated with the high estrogen/progesterone state)
- Irreversibly impaired brainstem function (bilateral fixed, dilated pupils and
extensor motor posturing), GCS less than or equal to 4
- Historical Rankin score greater than or equal to 2
- Intraventricular hemorrhage requiring external ventricular drainage
- Internal bleeding, involving retroperitoneal sites, or the gastrointestinal,
genitourinary, or respiratory tracts
- Superficial or surface bleeding, observed mainly at vascular puncture and access
sites (e. g., venous cutdowns, arterial punctures) or site of recent surgical
intervention
- Known risk for embolization, including history of left heart thrombus, mitral
stenosis with atrial fibrillation, acute pericarditis, and subacute bacterial
endocarditis
- In the investigator's opinion, the patient is unstable and would benefit from a
specific intervention rather than supportive care plus or minus MIS+rtPA
- Prior enrollment in the study
- Any other condition that the investigator believes would pose a significant hazard to
the subject if the investigational therapy were initiated
- Participation in another simultaneous trial of ICH treatment.
Universitatsklinikum Erlangen, Erlangen, Germany; Not yet recruiting
Juergen Bardutzky, Email: juergen.bardutzky@uk-erlangen.de
Universitatsmedizin Goettingen, Goettingen, Germany; Not yet recruiting
Rhode Viet, Email: viet.rhode@med.uni-goettingen.de
University of Heidelberg, Heidelberg 69117, Germany; Not yet recruiting
Sylvia Treiber, Email: sylvia.treiber@med.uni-heidelberg.de
University of Cambridge, Cambridge, United Kingdom; Not yet recruiting
Ming-Yuan Tseng, Phone: + 44 1223 33 1763, Email: myt22@cam.ac.uk
Newcastle General Hospital, Newcastle, United Kingdom; Recruiting
Barbara Gregson, PhD, Phone: +44 191 233 6161, Ext: 22175, Email: barbara.gregson@ncl.ac.uk
David Mendelow, MD, Principal Investigator
University of California Los Angeles, Los Angeles, California 90095, United States; Recruiting
Maria Etchepare, Phone: 310-825-9121, Email: metchepare@mednet.ucla.edu
Neil Martin, MD, Principal Investigator
Paul Vespa, MD, Principal Investigator
Stanford University, Palo Alto, California 94034, United States; Recruiting
Ryan Snyder, Phone: 650-736-7648, Email: rsnider@stanford.edu
Christine Wijman, MD, Principal Investigator
University of California San Francisco, San Francisco, California 94143, United States; Not yet recruiting
Michele Meeker, Phone: 415-206-3200, Email: meekerm@neurosurg.ucsf.edu
Adam Kincaid, Phone: 415-206-4457, Email: akincaid@neurosurg.ucsf.edu
Georgetown University, Washington, District of Columbia 20007, United States; Recruiting
Courtney Hsieh, Phone: 202-687-6491, Email: ch462@georgetown.edu
Chelsea S Kidwell, MD, Principal Investigator
Mayo Clinic, Jacksonville, Florida 32216, United States; Recruiting
Alexa Richie, Phone: 904-953-7839, Email: richie.alexa@mayo.edu
Ronald Reimer, MD, Principal Investigator
Rush University, Chicago, Illinois 60612, United States; Recruiting
Terry Cole, Phone: 312-563-2208, Email: Terry_Cole@rush.edu
Richard Temes, MD, MS, Principal Investigator
NorthShore University Health System, Evanston, Illinois 60201, United States; Recruiting
Jennifer Jaffe, Phone: 847-570-1675, Email: jjaffe@northshore.org
Issam Awad, MD, Principal Investigator
Loyola University Medical Center, Maywood, Illinois 60153, United States; Withdrawn
Johns Hopkins University/Bayview Medical Center, Baltimore, Maryland 21287, United States; Recruiting
Satish Chandolu, Phone: 410-955-5000, Email: schando1@jhmi.edu
Judy Huang, MD, Principal Investigator
University of Maryland Medical Systems, Baltimore, Maryland 21201, United States; Recruiting
Charlene Aldrich, RN, Phone: 410-328-5332, Email: CALDRICH@smail.umaryland.edu
E. Francois Aldrich, MD, Principal Investigator
Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Meaghan Whalen, Phone: 617-726-7544, Email: mbwhalen@partners.org
Diedre Buckley, Phone: 617-726-5531, Email: dbuckley@parners.org
Bronson Medical Hospital, Kalamazoo, Michigan 49007, United States; Withdrawn
ST. Luke's Hospital, Kansas City, Missouri 64111, United States; Withdrawn
New Jersey Medical School, Edison, New Jersey 08818, United States; Recruiting
Albert Obiozo, MD, Phone: 732-321-7000, Ext: 68897, Email: aobiozo@solarishs.org
Kevin Crutchfield, MD, Principal Investigator
Mt. Sinai Medical Center, New York, New York 10029, United States; Recruiting
Sandra Augustine, RN, Phone: 212-241-1665, Email: sandra.augustine@mountsinai.org
Joshua Bederson, MD, Principal Investigator
Duke University Medical Center, Durham, North Carolina 27710, United States; Withdrawn
University of Cincinnati, Cincinnati, Ohio 45267, United States; Recruiting
Carolyn Koenig, Phone: 513-558-3518, Email: koenigch@ucmail.uc.edu
Becky Reinert, Phone: 513-558-0496, Email: gibsonrk@ucmail.uc.edu
Mario Zuccarello, MD, Principal Investigator
Case Western University, Cleveland, Ohio 44106, United States; Recruiting
Valerie Cwiklinski, Phone: 216-983-5144, Email: valerie.cwiklinsk@uhhospitals.org
Alan Hoffer, MD, Principal Investigator
Temple University, Philadelphia, Pennsylvania 19140, United States; Recruiting
Emerson Clement, PhD, Phone: 215-707-4071, Email: emerson.clement@tuhs.temple.edu
Christopher Loftus, Principal Investigator
Thomas Jefferson University, Philadelphia, Pennsylvania 19107, United States; Recruiting
Mary Ann Sheridan, Email: maryann.sheridan@jefferson.edu
Jack Jallo, MD, Principal Investigator
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15213, United States; Recruiting
Deborah Crowley, Phone: 412-647-4992, Email: crowleyda@upmc.edu
Sharon DeCesare, CCRC, Phone: 412-647-8445, Email: decesares@upmc.edu
Larence Wechsler, MD, Principal Investigator
Montreal Neurological Institute at McGill University, Montreal, Quebec H3A 2B4, Canada; Recruiting
Nelly Delouya, Phone: 514-398-5903, Email: nelly.delouya@mcgill.ca
David Sinclair, MD, FRCSC, Principal Investigator
Medical University of South Carolina, Charleston, South Carolina 29425, United States; Recruiting
Marc Lapointe, Phone: 843-792-2993, Email: lapointe@musc.edu
Dilantha Ellegala, Principal Investigator
University of Texas, Houston, Houston, Texas 77030, United States; Not yet recruiting
Karinda Langford, BS, Phone: 713-500-6624, Email: karinda.langford@uth.tmc.edu
George Lopez, MD,PhD, Principal Investigator
University of Texas HSC, San Antonio, San Antonio, Texas 78229, United States; Recruiting
Anne Leonard, Phone: 210-567-5625, Email: leonarda@uthscsa.edu
Jean-Louis Caron, MD, Principal Investigator
Inova Fairfax Hospital, Fairfax, Virginia 22042, United States; Not yet recruiting
Janet Rosecan, Phone: 703-776-4223, Email: janet.rosecan@inova.org
Virginia Commonwealth University, Richmond, Virginia 23298, United States; Recruiting
Randall Merchant, PhD, Phone: 804-828-9528, Email: rmerchan@hsc.vcu.edu
William Broaddus, MD, Principal Investigator
