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| Sponsor: | Johns Hopkins University |
|---|---|
| Collaborators: |
National Institutes of Health (NIH) Genentech |
| Information provided by: | Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00224770 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Intracerebral Hemorrhage |
Drug: Cathflo Activase (drug) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
| Official Title: | Minimally Invasive Surgery Plus rtPA for Intracerebral Hemorrhage Evacuation |
| Estimated Enrollment: | 110 |
| Study Start Date: | August 2005 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Medical Managment: Active Comparator |
Drug: 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, 1.0, or 3.0 mg of recombinant tissue plasminogen activator, rt-PA, CathFlo®) through the catheter once every eight hours for up to 72 hours with best medical care.
|
| Surgical Management: Active Comparator |
Drug: 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, 1.0, or 3.0 mg of recombinant tissue plasminogen activator, rt-PA, CathFlo®) through the catheter once every eight hours for up to 72 hours with best medical care.
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Karen Lane, CCRP | 410-614-6996 | klane@jhmi.edu |
Hide Study Locations| United States, California | |
| University of California Los Angeles | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Jennifer Varma, MSN 310-825-4095 jvarma@mednet.ucla.edu | |
| Principal Investigator: Neil Martin, MD | |
| Stanford University | Recruiting |
| Palo Alto, California, United States, 94034 | |
| Contact: Ryan Snyder 650-736-7648 rsnider@stanford.edu | |
| Principal Investigator: Christine Wijman, MD | |
| University of California San Francisco | Not yet recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Michele Meeker 415-206-3200 meekerm@neurosurg.ucsf.edu | |
| Contact: Adam Kincaid 415-206-4457 akincaid@neurosurg.ucsf.edu | |
| United States, District of Columbia | |
| Georgetown University | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Contact: Shoshana Goldberg 202-784-0757 sg434@georgetown.edu | |
| Principal Investigator: Chelsea S Kidwell, MD | |
| United States, Florida | |
| Mayo Clinic | Recruiting |
| Jacksonville, Florida, United States, 32216 | |
| Contact: Alexa Richie 904-953-7839 richie.alexa@mayo.edu | |
| United States, Illinois | |
| Rush University | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Susan Dvojack, MS 312-563-2208 Susan_A_Dvojack@rush.edu | |
| Principal Investigator: Richard Temes, MD, MS | |
| NorthShore University Health System | Recruiting |
| Evanston, Illinois, United States, 60201 | |
| Contact: Jennifer Jaffe 847-570-1675 jjaffe@northshore.org | |
| Principal Investigator: Issam Awad, MD | |
| Loyola University Medical Center | Recruiting |
| Maywood, Illinois, United States, 60153 | |
| Contact: Linda Chadwick, BSN, RN 708-216-6638 lchadwick@lumc.edu | |
| Principal Investigator: Michael J Schneck, MD | |
| United States, Maryland | |
| Johns Hopkins University/Bayview Medical Center | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Shannon LeDroux 410-502-0505 sledrou1@jhmi.edu | |
| Principal Investigator: Judy Huang, MD | |
| University of Maryland Medical Systems | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Charlene Aldrich, RN 410-328-5332 CALDRICH@smail.umaryland.edu | |
| Principal Investigator: E. Francois Aldrich, MD | |
| United States, Massachusetts | |
| Massachusetts General Hospital | Not yet recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Meaghan Whalen 617-726-7544 mbwhalen@partners.org | |
| Contact: Diedre Buckley 617-726-5531 dbuckley@parners.org | |
| United States, Michigan | |
| Bronson Medical Hospital | Recruiting |
| Kalamazoo, Michigan, United States, 49007 | |
| Contact: Karen Bergman, RN, Phdc 269-341-7587 bergmank@bronsonhg.org | |
| Principal Investigator: Jeffrey Fletcher, MD | |
| United States, Missouri | |
| ST. Luke's Hospital | Recruiting |
| Kansas City, Missouri, United States, 64111 | |
| Contact: Jennifer McIntire, RN 816-932-7985 jmcintire@saint-lukes.org | |
| Principal Investigator: Paula Camarata, MD | |
| United States, New Jersey | |
| New Jersey Medical School | Recruiting |
| Edison, New Jersey, United States, 08818 | |
| Contact: Albert Obiozo, MD 732-321-7000 ext 68897 aobiozo@solarishs.org | |
| Principal Investigator: Kevin Crutchfield, MD | |
| United States, New York | |
| Mt. Sinai Medical Center | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Sandra Augustine, RN 212-241-1665 sandra.augustine@mountsinai.org | |
| Principal Investigator: Joshua Bederson, MD | |
| Columbia University | Not yet recruiting |
| New York, New York, United States, 10027 | |
| Contact: Lashana Lewis 212-342-1188 lsl2109@columbia.edu | |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Joanna Stoner 919-668-5275 stone034@bronsonhg.org | |
| Principal Investigator: Carmelo Graffagnino, MD | |
| United States, Ohio | |
| University of Cincinnati | Recruiting |
| Cincinnati, Ohio, United States, 45267 | |
| Contact: Carolyn Koenig 513-558-3518 koenigch@ucmail.uc.edu | |
| Contact: Becky Reinert 513-558-0496 gibsonrk@ucmail.uc.edu | |
| Principal Investigator: Mario Zuccarello, MD | |
| Case Western University | Not yet recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Valerie Cwiklinski 216-983-5144 valerie.cwiklinsk@uhhospitals.org | |
| United States, Pennsylvania | |
| Temple University | Recruiting |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Contact: Emerson Clement, PhD 215-707-4071 emerson.clement@tuhs.temple.edu | |
| Principal Investigator: Christopher Loftus | |
| Thomas Jefferson University | Not yet recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Deborah August 215-503-1984 deborah.august@jefferson.edu | |
| University of Pittsburgh Medical Center | Not yet recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Deborah Crowley 412-647-4992 crowleyda@upmc.edu | |
| Contact: Sharon DeCesare, CCRC 412-647-8445 decesares@upmc.edu | |
| Principal Investigator: Larence Wechsler, MD | |
| United States, South Carolina | |
| Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: Marc Lapointe 843-792-2993 lapointe@musc.edu | |
| Principal Investigator: Dilantha Ellegala | |
| United States, Texas | |
| Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Karinda Langford, BS 713-798-7518 kjlangofo@bcm.tmc.edu | |
| Principal Investigator: George Lopez, MD,PhD | |
| University of Texas HSC, San Antonio | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Anne Leonard 210-567-5625 leonarda@uthscsa.edu | |
| Principal Investigator: Jean-Louis Caron, MD | |
| United States, Virginia | |
| Inova Fairfax Hospital | Not yet recruiting |
| Fairfax, Virginia, United States, 22042 | |
| Contact: Janet Rosecan 703-776-4223 janet.rosecan@inova.org | |
| Virginia Commonwealth University | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Contact: Randall Merchant, PhD 804-828-9528 rmerchan@hsc.vcu.edu | |
| Principal Investigator: William Broaddus, MD | |
| Canada, Quebec | |
| Montreal Neurological Institute at McGill University | Recruiting |
| Montreal, Quebec, Canada, H3A 2B4 | |
| Contact: Nelly Delouya 514-398-5903 nelly.delouya@mcgill.ca | |
| Principal Investigator: David Sinclair, MD, FRCSC | |
| Germany | |
| Universitatsklinikum Erlangen | Not yet recruiting |
| Erlangen, Germany | |
| Contact: Juergen Bardutzky juergen.bardutzky@uk-erlangen.de | |
| Universitatsmedizin Goettingen | Not yet recruiting |
| Goettingen, Germany | |
| Contact: Rhode Viet viet.rhode@med.uni-goettingen.de | |
| University of Heidelberg | Not yet recruiting |
| Heidelberg, Germany, 69117 | |
| Contact: Sylvia Treiber sylvia.treiber@med.uni-heidelberg.de | |
| United Kingdom | |
| University of Cambridge | Not yet recruiting |
| Cambridge, United Kingdom | |
| Contact: Ming-Yuan Tseng + 44 1223 33 1763 myt22@cam.ac.uk | |
| Newcastle General Hospital | Not yet recruiting |
| Newcastle, United Kingdom | |
| Contact: Barbara Gregson, PhD +44 191 233 6161 ext 22175 barbara.gregson@ncl.ac.uk | |
| Principal Investigator: David Mendelow, MD | |
| Study Chair: | Daniel F. Hanley, MD | Johns Hopkins University |
| Principal Investigator: | Mario Zuccarello, MD | University of Cincinnati |
More Information
| Responsible Party: | Johns Hopkins University ( Daniel F. Hanley, MD ) |
| Study ID Numbers: | ICH01, 1 R01 NS046309-01 A1 |
| Study First Received: | September 21, 2005 |
| Last Updated: | July 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00224770 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Cerebral Hemorrhage Molecular Mechanisms of Pharmacological Action Hematologic Agents Nervous System Diseases Vascular Diseases Central Nervous System Diseases Tissue Plasminogen Activator Fibrinolytic Agents Cardiovascular Agents |
Intracranial Hemorrhages Hemorrhage Brain Diseases Cerebrovascular Disorders Pharmacologic Actions Fibrin Modulating Agents Pathologic Processes Therapeutic Uses Cardiovascular Diseases |