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Minimally Invasive Surgery and rtPA for Intracerebral Hemorrhage Evacuation

Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Intracerebral Hemorrhage

Intervention: MIS+Cathflo Activase (drug) (Drug); Intraoperative stereotactic CT-Guided Endoscopic Surgery (Procedure)

Phase: Phase 2

Status: Completed

Sponsored by: Daniel Hanley

Official(s) and/or principal investigator(s):
Daniel F. Hanley, MD, Study Chair, Affiliation: Johns Hopkins University
Mario Zuccarello, MD, Principal Investigator, Affiliation: University of Cincinnati
Paul Vespa, MD, Principal Investigator, Affiliation: University of California, Los Angeles

Summary

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 ICES arm of the trial will determine the safety of endoscopic surgery to remove ICH. All MISTIE intention to treat subjects represent the hypothesized test group. The ICES cohort is to be analyzed separately.

Clinical Details

Official title: Minimally Invasive Surgery and rtPA for Intracerebral Hemorrhage Evacuation

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Safety Outcome Number 1: Rate of Mortality

Safety Outcome Number 2: Rate of Procedure-related Mortality

Safety Outcome Number 3: Rate of Cerebritis, Meningitis, Bacterial Ventriculitis

Safety Outcome Number 4: Rate of Symptomatic Rebleeding

Efficacy Outcome Number 1: Dichotomized Modified Rankin Scale (mRS) at Day 180

Secondary outcome:

Ordinal Modified Rankin Scale (mRS) at Day 180

Ordinal Modified Rankin Scale (mRS) at Day 365

Clot Size Reduction by End of Treatment

Post-operative Clot Size Reduction

Detailed description: 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. The Intraoperative stereotactic CT-guided Endoscopic Surgery (ICES) arm of the trial will determine the safety, feasibility and effectiveness of endoscopic surgery to remove ICH. This tests the first step of the MISTIE surgical procedure with an endoscope, not a rigid cannula. We propose to test if these interventions facilitate 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 these interventions and assess their ability to remove blood clot from brain tissue.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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) (Does not apply to ICES Tier)

- 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 (Does not apply to ICES Tier)

- Superficial or surface bleeding, observed mainly at vascular puncture and access

sites (e. g., venous cutdowns, arterial punctures) or site of recent surgical intervention (Does not apply to ICES Tier)

- Known risk for embolization, including history of left heart thrombus, mitral

stenosis with atrial fibrillation, acute pericarditis, and subacute bacterial endocarditis (Does not apply to ICES Tier)

- 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.

Locations and Contacts

University of Heidelberg, Heidelberg 69117, Germany

Newcastle General Hospital, Newcastle, United Kingdom

University of Alabama at Birmingham, Birmingham, Alabama 35294, United States

Barrow Neurosurgical Associates, Phoenix, Arizona 85013, United States

University of California Los Angeles, Los Angeles, California 90095, United States

Stanford University, Palo Alto, California 94034, United States

University of California, San Diego, San Diego, California 92103, United States

Hartford Hospital, Hartford, Connecticut 06102, United States

Georgetown University, Washington, District of Columbia 20007, United States

Mayo Clinic, Jacksonville, Florida 32216, United States

Rush University, Chicago, Illinois 60612, United States

University of Chicago, Chicago, Illinois 60637, United States

NorthShore University Health System, Evanston, Illinois 60201, United States

Johns Hopkins University/Bayview Medical Center, Baltimore, Maryland 21287, United States

University of Maryland Medical Systems, Baltimore, Maryland 21201, United States

Henry Ford Health System, Detroit, Michigan 48202, United States

JFK Medical Center New Jersey, Edison, New Jersey 08818, United States

Mt. Sinai Medical Center, New York, New York 10029, United States

University of Cincinnati, Cincinnati, Ohio 45267, United States

Case Western University, Cleveland, Ohio 44106, United States

Temple University, Philadelphia, Pennsylvania 19140, United States

Thomas Jefferson University, Philadelphia, Pennsylvania 19107, United States

Allegheny General Hospital, Pittsburgh, Pennsylvania 15212, United States

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15213, United States

Montreal Neurological Institute at McGill University, Montreal, Quebec H3A 2B4, Canada

Medical University of South Carolina, Charleston, South Carolina 29425, United States

University of Texas, Houston, Houston, Texas 77030, United States

University of Texas HSC, San Antonio, San Antonio, Texas 78229, United States

Virginia Commonwealth University, Richmond, Virginia 23298, United States

Additional Information

Trial website

Starting date: August 2005
Last updated: June 17, 2015

Page last updated: August 20, 2015

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