Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation Phase III



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:12/13/2018
Start Date:December 30, 2013
End Date:September 2018

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A phase III, randomized, case-controlled, open-label, 500-subject clinical trial of minimally
invasive surgery plus rt-PA in the treatment of intracerebral hemorrhage (ICH).

Primary Objectives:

Efficacy: Demonstrate that minimally invasive surgery (MIS) plus recombinant tissue
plasminogen activator (rt-PA) for three days improves functional outcome by a 12% increase in
the modified Rankin Scale (mRS) score 0-3 compared to medically treated subjects assessed at
365 days.

Secondary Objective:

Demonstrate that the end of treatment volume and percent of ICH reduction from MIS+rt-PA is
related to improved functional outcome, as compared to medically treated subjects.

Safety:

Demonstrate that early use of MIS+rt-PA for three days is safe for the treatment of ICH
relative to rates of mortality, rebleeding, and infection in the medically treated subject at
30 days.

Inclusion Criteria:

- Spontaneous supratentorial ICH ≥ 30 mL diagnosed using radiographic imaging
(computerized tomography (CT), computerized tomography angiography (CTA), etc.), with
a Glasgow Coma Scale (GCS) ≤ 14 or a NIHSS ≥ 6.

- Stability CT scan done at least 6 hours after diagnostic CT showing clot stability
(growth < 5 mL as measured by ABC/2 method).

- Symptoms less than 24 hours prior to diagnostic CT (dCT) scan (an unknown time of
onset is exclusionary).

- Ability to randomize between 12 and 72 hours after dCT.

- Systolic Blood Pressure (SBP) < 180 mmHg sustained for six hours recorded closest to
the time of randomization.

- Historical Rankin score of 0 or 1.

- Age ≥ 18 and older.

Exclusion Criteria:

- Infratentorial hemorrhage.

- Intraventricular hemorrhage (IVH) requiring treatment for IVH-related (casting) mass
effect or shift due to trapped ventricle. External ventricular drain (EVD) to treat
intracranial pressure (ICP) is allowed.

- Thalamic bleeds with apparent midbrain extension with third nerve palsy or dilated and
non-reactive pupils. Other (supranuclear) gaze abnormalities are not exclusions. Note:
Patients with a posterior fossa ICH or cerebellar hematomas are ineligible.

- Irreversible impaired brain stem function (bilateral fixed, dilated pupils and
extensor motor posturing), GCS ≤ 4.

- Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya
disease, hemorrhagic conversion of an ischemic infarct, recurrence of a recent (< 1
year) hemorrhage diagnosed with radiographic imaging.

- Patients with unstable mass or evolving intracranial compartment syndrome.

- Platelet count < 100,000; international normalized ratio (INR) > 1.4.

- Any irreversible coagulopathy or known clotting disorder.

- Inability to sustain INR ≤ 1.4 using short- and long-active procoagulants (such as but
not limited to NovoSeven, Fresh Frozen Plasma (FFP), and/or vitamin K).

- Subjects requiring long-term anti-coagulation are excluded. Reversal of
anti-coagulation is permitted for medically stable patients who can realistically
tolerate the short term risk of reversal. Patient must not require Coumadin
(anticoagulation) during the first 30 days, and normalized coagulation parameters must
be demonstrated, monitored closely and maintained during the period of brain
instrumentation.

- Use of Dabigatran, Apixaban, and/or Rivaroxaban (or a similar medication from the
similar medication class) prior to symptom onset.

- 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, etc.) or site of recent surgical
intervention.

- Positive urine or serum pregnancy test in pre-menopausal female subjects without a
documented history of surgical sterilization.

- Allergy/sensitivity to rt-PA.

- Prior enrollment in the study.

- Participation in a concurrent interventional medical investigation or clinical trial.
Patients in observational, natural history, and/or epidemiological studies not
involving an intervention are eligible.

- Not expected to survive to the day 365 visit due to co-morbidities and/or are do not
resuscitate (DNR)/ do not intubate (DNI) status prior to randomization.

- 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 heart valve. Presence of bio-prosthetic valve(s) is
permitted.

- Known risk for embolization, including history of left heart thrombus, mitral stenosis
with atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis.

- Any other condition that the investigator believes would pose a significant hazard to
the subject if the investigational therapy were initiated.

- Active drug or alcohol use or dependence that, in the opinion of the site
investigator, would interfere with adherence to study requirements.

- In the investigator's opinion, the patient is unstable and would benefit from a
specific intervention rather than supportive care plus or minus MIS+rt-PA removal of
the ICH.

- Inability or unwillingness of subject or legal guardian/representative to give written
informed consent.
We found this trial at
57
sites
Syracuse, New York 13214
Principal Investigator: Eric Deshaies
Phone: 315-464-5502
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Wendy Ziai
Phone: 410-955-6488
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Mark Harrigan
Phone: 205-999-3873
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
Principal Investigator: Mario Zuccarello
Phone: 513-558-3590
University of Cincinnati Medical Center Opening in 1823 as the country
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Los Angeles, California 90095
310-825-4321
Phone: 310-267-7433
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Matthew Fusco
Phone: 615-322-6263
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Principal Investigator: J. Mocco
Phone: 212-241-2220
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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22 Bramhall St
Portland, Maine 04102
(207) 662-0111
Principal Investigator: David Seder, MD
Phone: 207-662-2066
Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Safdar Ansari
Phone: 801-585-9266
University of Utah Research is a major component in the life of the U benefiting...
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Principal Investigator: Larami McKenzie
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Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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Albuquerque, New Mexico 87131
(505) 277-0111
Principal Investigator: Andrew Carlson, MD
Phone: 505-272-3417
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
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Phone: 734-647-5436
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Baltimore, Maryland 20742
(301) 405-1000
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Buffalo, New York 14215
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Phone: 716-888-4812
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Camperdown, New South Wales 2050
Phone: 02 9515 7544
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Carmichael, California 95608
Principal Investigator: Alex Nee
Phone: 916-864-8370
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Phone: 843-792-3164
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Charlottesville, Virginia 22908
Principal Investigator: Kenneth Liu
Phone: 434-243-9986
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Babak S. Jahromi, MD
Phone: 312-926-9445
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Chicago, Illinois 60612
Principal Investigator: George Lopez
Phone: 312-942-6731
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2035 W Taylor St
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(312) 996-4350
Principal Investigator: Sepideh Amin-Hanjani
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
Principal Investigator: Agnieszka "Anise" Ardelt, MD, PhD
Phone: 773-702-8996
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Dallas, Texas 75390
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1 Wyoming St,
Dayton, Ohio 45409
(937) 208-8000
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Detroit, Michigan 48202
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Phone: 313-333-9640
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Michael James
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Evanston, Illinois 60201
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Falls Church, Virginia 22042
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80 Seymour St
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Houston, Texas 77030
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Jacksonville, Florida 32216
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
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Kansas City, Missouri 64111
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La Jolla, California 92037
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Lawrenceville, Georgia 30045
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
Phone: 502-813-6579
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Madison, Wisconsin 53792
(608) 263-2400
Principal Investigator: Azam Ahmed
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Manhasset, New York 11030
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Maywood, Illinois 60153
Principal Investigator: Michael Schneck, MD
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Minneapolis, Minnesota 55414
Principal Investigator: Thomas Bergman
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Murray, Utah 84107
Principal Investigator: Robert Hoesch
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New Brunswick, New Jersey 08903
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New Haven, Connecticut 6520
(203) 432-4771
Phone: 203-785-7887
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New York, New York 10021
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Philadelphia, Pennsylvania 19140
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
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Phoenix, Arizona 85006
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Phoenix, Arizona 85013
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
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Portland, Oregon 97225
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Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: William Broaddus
Phone: 804-628-7975
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Saint Louis, Missouri 63110
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San Antonio, Texas 78249
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San Diego, California 92093
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
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1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
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