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Trial record 1 of 1 for:    nct00784134
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Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR III)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00784134
First Posted: November 3, 2008
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Genentech, Inc.
Emissary International LLC
Information provided by (Responsible Party):
Johns Hopkins University
  Purpose
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).

Condition Intervention Phase
Intraventricular Hemorrhage Drug: Alteplase Other: Normal saline Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Participants With Modified Rankin Scale (mRS) <=3 - Dichotomized Analysis [ Time Frame: 180 days ]
    Analysis modified on September 29, 2015 to account for adaptive randomization. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).

  • Participant Score on the Modified Rankin Scale (mRS) - Ordinal Analysis [ Time Frame: 180 days ]
    The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).

  • Participants With Modified Rankin Scale (mRS) <=4 - Dichotomized Analysis [ Time Frame: 180 days ]
    The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).

  • Random Effects Assessment of Site Effect on Modified Rankin Scale (mRS) <= 3 [ Time Frame: 180 days ]
    The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).

  • Longitudinal Assessment of Participants With Modified Rankin Scale (mRS) <=3 [ Time Frame: 30 days and 180 days ]
    Comparing longitudinal modified Rankin Scale (mRS) scores 0-3 at Day 30 and Day 180. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).


Secondary Outcome Measures:
  • All Cause Mortality [ Time Frame: 180 days ]
  • Clot Removal (Amount of Residual Blood) [ Time Frame: 72 hours ]
    Change in blood volume measured between stability scan and end of treatment scan

  • Intensity of Critical Care Management - Hospital Days [ Time Frame: 30 days ]
    Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.

  • Intensity of Critical Care Management - ICU Days [ Time Frame: 30 days ]
    Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.

  • Intensity of Critical Care Management - ICP Management [ Time Frame: 30 days ]
    Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.

  • Intensity of Critical Care Management - Mechanical Ventilation [ Time Frame: 30 days ]
    Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.

  • Intensity of Critical Care Management - Pressors [ Time Frame: 30 days ]
    Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.

  • Intensity of Critical Care Management - Shunts [ Time Frame: 30 days ]
    Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.

  • Intensity of Critical Care Management - All Infections [ Time Frame: 30 days ]
    Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.

  • Intensity of Critical Care Management - Pneumonia [ Time Frame: 30 days ]
    Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.

  • Intensity of Critical Care Management - All Infections [ Time Frame: 180 days ]
    Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections.

  • Safety/Mortality - Mortality Within 30 Days [ Time Frame: 30 days ]
    Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.

  • Safety/Mortality - Bacterial Brain Infections Within 30 Days [ Time Frame: 30 days ]
    Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.

  • Safety/Mortality - Systematic Bleeds Within 72 Hours [ Time Frame: 72 hours ]
    Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.

  • Safety/Mortality - Systematic Bleeds Within 30 Days [ Time Frame: 30 days ]
    Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality.

  • Adverse and Serious Adverse Events [ Time Frame: 180 days ]
    Assessment of number of adverse and serious adverse events by treatment group.

  • Predicting Hazards of Death by Treatment Group [ Time Frame: 180 days ]
    Cox Proportional Hazards Model is used to predict the hazards ratio by treatment group.

  • Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (African-American) [ Time Frame: 180 days ]
    Assessment of modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).

  • Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (White) [ Time Frame: 180 days ]
    Assessment of modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).

  • Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Female) [ Time Frame: 180 days ]
    Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).

  • Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Male) [ Time Frame: 180 days ]
    Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).

  • Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (65 Years or Under) [ Time Frame: 180 days ]
    Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).

  • Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (Over 65 Years) [ Time Frame: 180 days ]
    Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).

  • Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Less Than 20ml) [ Time Frame: 180 days ]
    Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).

  • Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (20-50ml) [ Time Frame: 180 days ]
    Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).

  • Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Greater Than 50ml) [ Time Frame: 180 days ]
    Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).

  • Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Thalamic) [ Time Frame: 180 days ]
    Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).

  • Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Non-Thalamic) [ Time Frame: 180 days ]
    Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death).

  • Functional Status - Barthel Index [ Time Frame: 180 days ]
    Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The Barthel Index (BI) assesses ten functional tasks of daily living, and each task provides a measure for level of independence. Scores range from 0 and 100, with a higher score indicating greater independence.

  • Functional Status - Participants With Extended Glasgow Outcome (eGOS) Score >=Upper Severe Disability [ Time Frame: 180 days ]
    Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The extended Glasgow Outcome Scale (eGOS) is a global scale for functional outcome with eight categories: 1 - Death, 2 - Vegetative State, 3 - Lower Severe Disability, 4 - Upper Severe Disability, 5 - Lower Moderate Disability, 6 - Upper Moderate Disability, 7 - Lower Good Recovery, 8 - Upper Good Recovery.

  • Functional Status - National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: 180 days ]
    Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The National Institutes of Health Stroke Scale (NIHSS) is a 15-item scale that assesses language, motor function, sensory loss, consciousness, visual fields, extraocular movements, coordination, neglect, and speech. It is scored from 0 (no stroke symptoms) to 42 (severe stroke).

  • Quality of Life - Stroke Impact Scale (SIS) - Strength [ Time Frame: 180 days ]
    Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.

  • Quality of Life - Stroke Impact Scale (SIS) - Mobility [ Time Frame: 180 days ]
    Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.

  • Quality of Life - Stroke Impact Scale (SIS) - Hand Function [ Time Frame: 180 days ]
    Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.

  • Quality of Life - Stroke Impact Scale (SIS) - Activities of Daily Living [ Time Frame: 180 days ]
    Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.

  • Quality of Life - Stroke Impact Scale (SIS) - Communication [ Time Frame: 180 days ]
    Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.

  • Quality of Life - Stroke Impact Scale (SIS) - Thinking [ Time Frame: 180 days ]
    Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.

  • Quality of Life - Stroke Impact Scale (SIS) - Emotion [ Time Frame: 180 days ]
    Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.

  • Quality of Life - Stroke Impact Scale (SIS) - Participation [ Time Frame: 180 days ]
    Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.

  • Quality of Life - Stroke Impact Scale (SIS) - Recovery [ Time Frame: 180 days ]
    Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health.

  • Quality of Life - EuroQol Visual Analogue Scale (EQ-VAS) [ Time Frame: 180 days ]
    Assessment of SIS and EuroQol Visual Analog Scale by group. EuroQol Visual Analogue Scale (EQ-VAS) is a self-reported measure of health status. It is a marked scale where individuals draw a line to indicate their health, with end points of 0 (the worst health you can imagine) and 100 (the best health you can imagine).


Enrollment: 500
Study Start Date: July 2009
Study Completion Date: January 2016
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alteplase
administration of alteplase via the intraventricular catheter
Drug: Alteplase
1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses
Other Names:
  • Cathflo Activase
  • rt-PA
Placebo Comparator: Saline Placebo
1 ml of normal saline administered via the intraventricular catheter
Other: Normal saline
1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00784134


  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Mayo Clinic, Arizona
Phoenix, Arizona, United States, 85054
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
University of Southern California - Keck School of Medicine
Los Angeles, California, United States, 90089
University of California Los Angeles
Los Angeles, California, United States, 90095
Stanford University
Palo Alto, California, United States, 94034
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06106
Yale University
New Haven, Connecticut, United States, 06520-8018
United States, District of Columbia
Georgetown University
Washington, D.C., District of Columbia, United States, 20007
United States, Florida
Mayo Clinic, Jacksonville
Jacksonville, Florida, United States, 32224
Intercoastal Medical Center
Sarasota, Florida, United States, 34232
University of South Florida
Tampa, Florida, United States, 33606
United States, Illinois
Rush University
Chicago, Illinois, United States, 60612
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
University of Chicago
Chicago, Illinois, United States, 60637
United States, Iowa
Ruan Neurology Clinical and Research Center
Des Moines, Iowa, United States, 50314
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
Johns Hopkins University
Baltimore, Maryland, United States, 21230
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Missouri
St. Luke's Brain and Stroke Institute
Kansas City, Missouri, United States, 64111
St. Louis University
Saint Louis, Missouri, United States, 63104
Springfield Neurological and Spine Institute
Springfield, Missouri, United States, 65804
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
New Jersey Neuroscience Institute at JFK
Edison, New Jersey, United States, 08818
United States, New York
University of Buffalo
Buffalo, New York, United States, 14203
Northshore University Hospital Long Island
Manhasset, New York, United States, 11030
Mount Sinai Hospital
New York, New York, United States, 10029
Columbia University
New York, New York, United States, 10032
SUNY Upstate Medical Center
Syracuse, New York, United States, 13210
United States, North Carolina
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Case-Western Reserve University Hospital
Cleveland, Ohio, United States, 44106
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Oregon
Maine Medical Center
Portland, Oregon, United States, 04102
Providence Stroke Center
Portland, Oregon, United States, 97225
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt
Nashville, Tennessee, United States, 37232
United States, Texas
University of Texas, Southwestern, Dallas
Dallas, Texas, United States, 75390
University of Texas, Houston
Houston, Texas, United States, 77030
University of Texas, San Antonio
San Antonio, Texas, United States, 78229
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Brazil
Hospital Sao Jose, Joinville
Joinville, Santa Catarina, Brazil, 89202165
Hospital de Clinicas de Porto Alegre
Porto Alegre, Brazil, 90035-903
Hospital de Pronto Socorro de Porto Alegre
Porto Alegre, Brazil
Hospital de Clinicas de Ribeirao Preto
Ribeirão Preto, Brazil, 14015-130
Hospital Sao Paulo Universidade Federal de Sao Paulo / UNIFESP
Sao Paulo, Brazil, 04039032
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Canada, Quebec
Montreal Neurological Institute at McGill University
Montreal, Quebec, Canada, H3A 2B4
Germany
University of Erlangen
Erlangen, Germany, 91054
University of Halle
Halle, Germany, D-06120
University of Heidelberg
Heidelberg, Germany, 69120
University of Leipzig
Leipzig, Germany, 04103
University of Mainz
Mainz, Germany, D-55131
University of Tubingen
Tübingen, Germany, 72076
Hungary
University of Szeged
Szeged, Csongrad, Hungary, 6725
Honved Korhaz
Budapest, Hungary, 1134
University of Debrecen
Debrecen, Hungary, 4032
University of Pecs
Pecs, Hungary, 7623
Israel
Rambam Medical Center
Haifa, Israel, 31096
Hadassah Hebrew University Hospital
Jerusalem, Israel, 91120
Chaim Sheba Medical Center
Ramat-Gan, Israel, 52621
Sourasky Medical Center
Tel Aviv, Israel, 64239
Spain
Bellvitge Hospital
Barcelona, Spain, 08015
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Vall d'Hebron University Hospital
Barcelona, Spain, 08035
Switzerland
University of Zurich
Zurich, ZH, Switzerland, CH-8091
University Hospital, Inselpital, Bern
Bern, Switzerland
United Kingdom
Salford Royal NHS Foundation Trust
Salford, Manchester, United Kingdom, M6 8HD
Newcastle General Hospital
Newcastle upon Tyne, United Kingdom, NE4 6BE
University of Southampton Hospital
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Johns Hopkins University
National Institute of Neurological Disorders and Stroke (NINDS)
Genentech, Inc.
Emissary International LLC
Investigators
Study Chair: Daniel F. Hanley, MD Johns Hopkins University
  More Information

Additional Information:
Study Data/Documents: Data repository-VISTA  This link exits the ClinicalTrials.gov site
Identifier: Data repository-VISTA
when available
Study Protocol  This link exits the ClinicalTrials.gov site
when available
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
when available

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00784134     History of Changes
Other Study ID Numbers: IVH06
5U01NS062851-05 ( U.S. NIH Grant/Contract )
First Submitted: October 31, 2008
First Posted: November 3, 2008
Results First Submitted: March 30, 2017
Results First Posted: July 2, 2017
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Johns Hopkins University:
intraventricular hemorrhage thrombolysis

Additional relevant MeSH terms:
Hemorrhage
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action