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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 |
Show 33 Study Locations| 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 |