Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 80
Updated:12/7/2018
Start Date:July 2009
End Date:January 2016

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The overall objective of this Phase III clinical trial is to obtain information from a
population of 500 ICH subjects with intraventricular hemorrhage (IVH), representative of
current clinical practice and national demographics of ICH regarding the benefit (or lack
thereof) of IVH clot removal on subject function as measured by modified Rankin Scale (mRS).
This application requests funding for five years to initiate a Phase III randomized clinical
trial (RCT) testing the benefit of clot removal for intraventricular hemorrhage. The
investigators propose to compare extraventricular drainage (EVD) use plus recombinant tissue
plasminogen activator (rt-PA; Alteplase; Genentech, Inc., San Francisco, CA) with EVD+
placebo in the management and treatment of subjects with small intracerebral hemorrhage (ICH)
and large intraventricular hemorrhage (IVH defined as ICH < 30 cc and obstruction of the 3rd
or 4th ventricles by intraventricular blood clot).


Inclusion Criteria:

- Age 18-80

- Symptom onset less than 24 hrs prior to diagnostic CT scan

- Spontaneous ICH less than or equal to 30 cc or primary IVH

- IVH obstructing 3rd and/or 4th ventricles

- ICH clot stability at 6 hours or more post IVC placement

- IVH clot stability at 6 hours or more post IVC placement

- Catheter tract bleeding stability 6 hours or more post IVC placement

- EVD placed per standard medical care

- SBP less than 200 mmHg sustained for 6 hours prior to drug administration

- Able to randomize within 72 hours of diagnostic CT scan

- Historical Rankin of 0 or 1

Exclusion Criteria:

- Suspected or untreated ruptured cerebral aneurysm, AVM, or tumor

- Presence of a choroid plexus vascular malformation or Moyamoya

- Clotting disorders

- Platelet count less than 100,000, INR greater than 1.4

- Pregnancy

- Infratentorial hemorrhage

- SAH at clinical presentation

- ICH/IVH enlargement that cannot be stabilized in the treatment time window

- Ongoing internal bleeding

- Superficial or surface bleeding

- 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

- Planned or simultaneous participation (between screening and Day-30) in another
interventional medical investigation or clinical trial.

- No subject or legal representative to give written informed consent
We found this trial at
53
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
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 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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Baltimore, Maryland 20742
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University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Buffalo, New York 14215
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1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Chicago, Illinois 60612
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
University of Illinois at Chicago A major research university in the heart of one of...
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Cleveland, OH
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Dallas, TX
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Detroit, Michigan 48202
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Edison, New Jersey 08818
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
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Hershey, Pennsylvania 17033
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Houston, Texas 77030
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Jacksonville, Florida 32216
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Joinville, Santa Catarina 89202
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Kansas City, Missouri 64111
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Manhasset, New York 11030
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Nashville, Tennessee 37212
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New Haven, Connecticut 6520
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Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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New York, New York 10029
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Palo Alto, California 94304
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5501 Old York Road
Philadelphia, Pennsylvania 19141
215-456-7890
Albert Einstein Medical Center Einstein Healthcare Network is a private, not-for-profit organization with several major...
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3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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111 S 11th St
Philadelphia, Pennsylvania 19107
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Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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Phoenix, Arizona 85054
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
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Portland, Oregon 04102
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Portland, Oregon 97225
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Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Saint Louis, Missouri 63110
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San Antonio, Texas 78249
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Sarasota, Florida 34232
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Springfield, Missouri 65804
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Syracuse, New York 13210
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3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
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Winston-Salem, North Carolina 27157
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