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| Sponsors and Collaborators: |
Johns Hopkins University 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 (MISTIE) |
| Estimated Enrollment: | 110 |
| Study Start Date: | August 2005 |
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: Nichol McBee, MPH, CCRP | 410-614-6996 | nmcbee@jhmi.edu |
| United States, Illinois | |
| Evanston Northwestern Healthcare | Recruiting |
| Evanston, Illinois, United States, 60201 | |
| Contact: Judith O'Leary, RN 847-570-1632 JOLeary@enh.org | |
| Principal Investigator: Issam Awad, MD | |
| United States, Maryland | |
| Johns Hopkins University | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Shannon Le Droux 410-502-0505 sledrou1@jhmi.edu | |
| Principal Investigator: Rafael Tamargo, MD | |
| Principal Investigator: Richard Clatterbuck, MD | |
| Sub-Investigator: Judy Huang, MD | |
| Sub-Investigator: Neal Naff, MD | |
| University of Maryland Medical Systems | Recruiting |
| Baltimore, Maryland, United States | |
| Contact: Charlene Aldrich, RN 410-328-5332 CALDRICH@smail.umaryland.edu | |
| Principal Investigator: Francois Aldrich, MD | |
| United States, Michigan | |
| Wayne State University | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Flicia Mada, RN 313-745-1893 fmada@med.wayne.edu | |
| Principal Investigator: William Coplin, MD | |
| Principal Investigator: Robert Johnson, MD | |
| United States, Missouri | |
| Washington University | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Brenda Hall 314-362-3559 | |
| Principal Investigator: Greg Zipfel, MD | |
| United States, New York | |
| Mt. Sinai Medical Center | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Fatima Sehba, PhD 212-241-6504 fatima.sehba@mssm.edu | |
| Principal Investigator: Joshua Bederson, MD | |
| United States, Ohio | |
| University of Cincinnati | Recruiting |
| Cincinnati, Ohio, United States, 45267 | |
| Contact: Suzanne Kempisty-Cliver, RN 513-558-3590 kempiss@ucmail.uc.edu | |
| Principal Investigator: Mario Zuccarello, MD | |
| United States, South Carolina | |
| Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: Bonnie Muntz-Pope, RN 843-792-8967 muntzpob@musc.edu | |
| Principal Investigator: Byron Bailey, MD | |
| Sub-Investigator: Marc Lapointe, PharmD | |
| United States, Virginia | |
| 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 | |
| Study Chair: | Daniel F. Hanley, MD | Johns Hopkins University |
| Principal Investigator: | Mario Zuccarello, MD | University of Cincinnati |
More Information
| Study ID Numbers: | ICH01, 1 R01 NS046309-01 A1 |
| Study First Received: | September 21, 2005 |
| Last Updated: | April 1, 2008 |
| ClinicalTrials.gov Identifier: | NCT00224770 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Fibrin Modulating Agents Cerebral Hemorrhage Vascular Diseases Tissue Plasminogen Activator Central Nervous System Diseases Fibrinolytic Agents |
Cardiovascular Agents Intracranial Hemorrhages Brain Diseases Hemorrhage Plasminogen Cerebrovascular Disorders |
|
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 |