Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 1 of 260 for:    CLEAR-III
Previous Study | Return to List | Next Study

Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR III)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Johns Hopkins University
Genentech, Inc.
Emissary International LLC
Information provided by (Responsible Party):
Daniel Hanley, Johns Hopkins University Identifier:
First received: October 31, 2008
Last updated: September 18, 2014
Last verified: September 2014

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 and Boehringer Ingelheim, Inc., Ingelheim, Germany) 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: Cathflo Activase
Other: Normal saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:
  • Modified Rankin Scale [ Time Frame: 180 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All cause mortality [ Time Frame: 180 days ] [ Designated as safety issue: No ]
  • Amount of residual blood [ Time Frame: 72 h ] [ Designated as safety issue: No ]
  • Intensity of critical care management [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: July 2009
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rt-PA
administration of rt-PA via the intraventricular catheter
Drug: Cathflo Activase
1.0 mg of Cathflo Activase 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
Other Name: normal saline


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00784134

Contact: Karen Lane, CMA, CCRP (410) 614-3461

  Hide Study Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Lisa Nelson    205-996-7109   
Contact: Mark Harrigan, MD    205-934-3131   
Principal Investigator: Mark Harrigan, MD         
United States, Arizona
Mayo Clinic, Arizona Terminated
Phoenix, Arizona, United States, 85054
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Felice Lin    310-248-7645   
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Courtney Real, RN    310-825-9121   
Contact: Paul Vespa, MD    310-267-9448   
Principal Investigator: Paul Vespa, MD         
University of Southern California - Keck School of Medicine Recruiting
Los Angeles, California, United States, 90089
Contact: Doris Arroyo    323-513-8133   
Contact: Benjamin Emanuel, DO    412-889-6413   
Principal Investigator: Benjamin Emanuel, DO         
Stanford University Recruiting
Palo Alto, California, United States, 94034
Contact: Madelleine Garcia    650-735-2326   
Contact: Chitra Venkatasubramanian, MD    650-723-4448   
Principal Investigator: Chitra Venkatasubramanian, MD         
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06106
Contact: Sara Jasak, RN    860-545-1005   
Contact: Inam Kureshi, MD    860-545-1911   
Principal Investigator: Inam Kureshi, MD         
Yale University Recruiting
New Haven, Connecticut, United States, 06520-8018
Contact: Janet Halliday, RN, BS    203-785-4146   
Contact: David Greer, MD   
Principal Investigator: David Greer, MD         
United States, District of Columbia
Georgetown University Terminated
Washington DC, District of Columbia, United States, 20007
United States, Florida
Mayo Clinic, Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Alexa Richie    904-953-7839   
Contact: William Freeman, MD    904-953-7229   
Principal Investigator: William Freeman, MD         
Intercoastal Medical Center Terminated
Sarasota, Florida, United States, 34232
University of South Florida Terminated
Tampa, Florida, United States, 33606
United States, Illinois
Rush University Recruiting
Chicago, Illinois, United States, 60612
Contact: Fumie Kita    312-942-2706   
Contact: Sayona John, MD    312-942-0728   
Principal Investigator: Sayona John, MD         
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Cedric McKoy    773-834-7854   
Contact: Agnieszka Ardelt, MD, PhD    773-702-6397   
Principal Investigator: Agnieszka Ardelt, MD, PhD         
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Maureen Hillmann    312-355-3863   
Contact: Fernando Testai, MD, PhD    312-355-3863   
Principal Investigator: Fernando Testai, MD PhD         
United States, Iowa
Ruan Neurology Clinical and Research Center Recruiting
Des Moines, Iowa, United States, 50314
Contact: Cheryl Inman, RN    515-358-0023   
Contact: Michael Jacoby, MD   
Principal Investigator: Michael Jacoby, MD         
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Heena Olalde, RN, MSN    319-356-8326   
Contact: Harold Adams, MD    319-356-8755   
Principal Investigator: Harold Adams, MD         
United States, Kansas
Kansas University Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Jason Gorup    913-588-1035   
Contact: Paul Camarata, MD    913-588-3915   
Principal Investigator: Paul Camarata, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21230
Contact: Mirinda Anderson White    410-955-6488   
Contact: Wendy Ziai, MD    410-955-7481   
Principal Investigator: Wendy Ziai, MD         
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Charlene Aldrich    410-328-5332   
Contact: Francois Aldrich, MD    410-328-0937   
Principal Investigator: Francois Aldrich, MD         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Lauren Tack    313-673-1787   
Contact: Panayiotis Varelas, MD    313-916-0596   
Principal Investigator: Panos Varelas, MD         
United States, Missouri
St. Luke's Brain and Stroke Institute Recruiting
Kansas City, Missouri, United States, 64111
Contact: Bridget Brion    816-932-9897   
Contact: Darren Lovick, MD    816-561-4655   
Principal Investigator: Darren Lovick, MD         
Springfield Neurological and Spine Institute Recruiting
Springfield, Missouri, United States, 65804
Contact: Jessica Ratcliff    417-885-3888 ext 1214   
Contact: H. Mark Crabtree, MD    417-885-3888   
Principal Investigator: H. Mark Crabtree, MD         
St. Louis University Terminated
St. Louis, Missouri, United States, 63104
United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08103
Contact: Cory Hackmyer    856-342-2460   
Contact: Thomas Mirsen, MD    856-342-2445   
Principal Investigator: Thomas Mirsen, MD         
New Jersey Neuroscience Institute at JFK Recruiting
Edison, New Jersey, United States, 08818
Contact: Charles Porbeni    732-321-7000 ext 68897   
Contact: Martin Gizzi, MD    732-321-7000 ext 65871   
Principal Investigator: Martin Gizzi, MD         
United States, New York
University of Buffalo Recruiting
Buffalo, New York, United States, 14203
Contact: Mary Hartney, RN    716-218-1000 ext 5105   
Contact: Jody Leonardo, MD    716-218-1000 ext 7128   
Principal Investigator: Jody Leonardo, MD         
Northshore University Hospital Long Island Recruiting
Manhasset, New York, United States, 11030
Contact: Cletus Cheyou    516-655-4340   
Contact: David LeDoux, MD    516-562-3064 ext 3593   
Principal Investigator: David Ledoux, MD         
Columbia University Active, not recruiting
New York, New York, United States, 10032
Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Contact: Sandra Augustine    212-241-1665   
Contact: Stanley Tuhrim    212-241-4562   
Principal Investigator: Stanley Tuhrim, MD         
SUNY Upstate Medical Center Recruiting
Syracuse, New York, United States, 13210
Contact: Iulia Movileanu    315-464-1670   
Contact: Julius Latorre, MD MPH    315-464-5014   
Principal Investigator: Julius Latorre, MD MPH         
United States, North Carolina
Wake Forest University Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Sara Vaughan, BA, CRC    336-716-8694   
Contact: Kristi Tucker, MD    336-716-1027   
Principal Investigator: Kristi Tucker, MD         
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Becky Reinert    513-558-0496   
Contact: Opeolu Adeoye, MD    513 558-0434    adeoyeo@UCMAIL.UC.EDU   
Principal Investigator: Opeolu Adeoye, MD         
Case-Western Reserve University Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Valerie Cwiklinski, RN    216-983-5144   
Contact: S. Alan Hoffer, MD    216-844-5744   
Principal Investigator: S. Alan Hoffer, MD         
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: April Spangler    614-293-4975   
Contact: Michel Torbey, MD    614-366-5681   
Principal Investigator: Michel Torbey, MD         
United States, Oregon
Maine Medical Center Recruiting
Portland, Oregon, United States, 04102
Contact: Barbara McCrum    207-662-2066   
Contact: David Seder, MD    207-662-4788   
Principal Investigator: David Seder, MD         
Providence Stroke Center Recruiting
Portland, Oregon, United States, 97225
Contact: Monica Rodriguez    503-216-1190   
Contact: David Antezana, MD    503.963.3100   
Principal Investigator: David Antezana, MD         
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Karin Jonczak, CRNP    215-481-5373   
Contact: Qaisar A Shah, MD    215-481-3145   
Principal Investigator: Qaisar A Shah, MD         
Penn State Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Deborah Hoffman    717-531-0003 ext 283063   
Contact: Kevin Cockroft, MD    717-531-1279   
Principal Investigator: Kevin Cockroft, MD         
Albert Einstein Medical Center Terminated
Philadelphia, Pennsylvania, United States, 19141
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Farah Sultan    215-707-4171   
Contact: Christopher Loftus, MD    215-707-7200   
Principal Investigator: Christopher Loftus, MD         
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Melissa Witt    215-955-3687   
Contact: Jack Jallo, MD, PhD    215-955-7000   
Principal Investigator: Jack Jallo, MD, PhD         
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Melissa Tian, RN    412-359-3748   
Contact: Ashis H Tayal, MD    412-359-8841   
Principal Investigator: Ashis H Tayal, MD         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Jennifer Oakley    412-605-3959   
Contact: Lawrence Wechsler, MD    412-647-8080   
Principal Investigator: Lawrence Wechsler, MD         
Sub-Investigator: Paul Gardner         
United States, South Carolina
Medical University of South Carolina Terminated
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt Recruiting
Nashville, Tennessee, United States, 37232
Contact: Chesney Oravec    703-935-3848   
Contact: J Mocco, MD, MS   
Principal Investigator: J Mocco, MD, MS         
United States, Texas
University of Texas, Southwestern, Dallas Active, not recruiting
Dallas, Texas, United States, 75390
University of Texas, Houston Active, not recruiting
Houston, Texas, United States, 77030
University of Texas, San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Esther Nanez    210-567-5625   
Contact: Jean-Louis Caron, MD    210-288-6540   
Principal Investigator: Jean-Louis Caron, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Julie Martinez    801-585-7027   
Contact: Safdar Ansari, MD    (801) 587-9953   
Principal Investigator: Safdar Ansari, MD         
United States, Virginia
Virginia Commonwealth University Terminated
Richmond, Virginia, United States, 23298
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Emon Das    414-805-2898   
Contact: Ann Helms, MD    414-805-5218   
Principal Investigator: Ann Helms, MD         
Hospital Sao Jose, Joinville Terminated
Joinville, Santa Catarina, Brazil, 89202165
Hospital de Clinicas de Porto Alegre Terminated
Porto Alegre, Brazil, 90035-903
Hospital de Pronto Socorro de Porto Alegre Terminated
Porto Alegre, Brazil
Hospital de Clinicas de Ribeirao Preto Terminated
Ribeirão Preto, Brazil, 14015-130
Hospital Sao Paulo Universidade Federal de Sao Paulo / UNIFESP Terminated
Sao Paulo, Brazil, 04039032
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Leka Sivakumar    780-248-1118   
Contact: Ken Butcher, MD    780-407-2171   
Principal Investigator: Ken Butcher, MD         
Canada, Quebec
Montreal Neurological Institute at McGill University Recruiting
Montreal, Quebec, Canada, H3A 2B4
Contact: Monica Abdou    514-398-1095   
Contact: David Sinclair, MD   
Principal Investigator: David Sinclair, MD         
University of Erlangen Recruiting
Erlangen, Germany, 91054
Contact: Dimitre Staykov    + 49-9131-8544539   
Contact: Hagen Huttner, MD    + 49-9131-8544523   
Principal Investigator: Hagen Huttner, MD         
University of Halle Recruiting
Halle, Germany, D-06120
Contact: Dana Richter    +49 (345) 5577033   
Contact: Katja Wartenberg, MD    +49 (345) 5572934 ext 2963   
Principal Investigator: Katja Wartenberg, MD         
University of Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Perdita Beck    0049-6221-56-38121   
Contact: Julian Bösel, MD    0049-6221-56-39145   
Principal Investigator: Julian Bösel, MD         
University of Leipzig Recruiting
Leipzig, Germany, 04103
Contact: Daniela Urban    +49 341 97 24 206   
Contact: Carsten Hobohm, MD   
Principal Investigator: Carsten Hobohm, MD         
University of Mainz Recruiting
Mainz, Germany, D-55131
Contact: Thomas Kerz, MD    00496131172006   
Principal Investigator: Thomas Kerz, MD         
University of Tubingen Recruiting
Tübingen, Germany, 72076
Contact: Julia Zeller    +4970712980417   
Contact: Sven Poli, MD    +49 7071 29-84427   
Principal Investigator: Sven Poli, MD         
University of Szeged Recruiting
Szeged, Csongrad, Hungary, 6725
Contact: Eniko Fako    +36 20 420 5834   
Contact: Pal Barzo    + 36 62 545-379   
Principal Investigator: Pal Barzo, MD         
Honved Korhaz Terminated
Budapest, Hungary, 1134
University of Debrecen Recruiting
Debrecen, Hungary, 4032
Contact: Katalin Szabo, MD    00 36 30 539 82 34   
Contact: Laszlo Csiba, MD    00-36-52-415176   
Principal Investigator: Laszlo Csiba, MD         
University of Pecs Recruiting
Pecs, Hungary, 7623
Contact: Peter Bukovics    003672535900 /7697      
Contact: Laszlo Szapary, MD, PhD    3672535918   
Principal Investigator: Laszlo Szapary, MD, PhD         
Rambam Medical Center Terminated
Haifa, Israel, 31096
Hadassah Hebrew University Hospital Recruiting
Jerusalem, Israel, 91120
Contact: Alex Furmanov    +972-50-8946868   
Contact: Guy Rosenthal, MD    +972-50-8573707   
Principal Investigator: Guy Rosenthal, MD         
Chaim Sheba Medical Center Recruiting
Ramat-Gan, Israel, 52621
Contact: Yulia Wasserman    +972-54-7202879   
Contact: Sagi Harnof, MD    972-52-6666291   
Principal Investigator: Sagi Harnof, MD         
Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Carmit Ben Harosh    972-3-6974397   
Contact: Nevo Margalit, MD    972-3-6973154   
Principal Investigator: Nevo Margalit, MD         
Bellvitge Hospital Recruiting
Barcelona, Spain, 08015
Contact: Carlos F Alarcon    0034664234935   
Contact: Alberto T Diaz    0034650324355   
Principal Investigator: Alberto T Diaz         
Vall d'Hebron University Hospital Recruiting
Barcelona, Spain, 08035
Contact: Alba Peña Paris    0034 934893512   
Contact: Fuat Arikan, MD    0034 93 489 4589   
Principal Investigator: Fuat Arikan, MD         
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Rebeca Marin Bueno    +34935537143   
Contact: Joan Marti-Fabregas    +34935565986   
Principal Investigator: Joan Marti-Fabregas         
University of Zurich Recruiting
Zurich, ZH, Switzerland, CH-8091
Contact: Benjamin Hertler, MD    +41 44 255 1111   
Contact: Andreas Luft, MD    +41 44 255 8806   
Principal Investigator: Andreas Luft, MD         
University Hospital, Inselpital, Bern Terminated
Bern, Switzerland
United Kingdom
Salford Royal NHS Foundation Trust Recruiting
Salford, Manchester, United Kingdom, M6 8HD
Contact: Victoria O'Loughlin    44 161 206 2188   
Contact: Hiren Patel    44 161 206 5059   
Principal Investigator: Hiren Patel, MD, PhD         
Newcastle General Hospital Recruiting
Newcastle upon Tyne, United Kingdom, NE4 6BE
Contact: Andrea Hughes    +44 1912823578   
Contact: A. David Mendelow    +44 191 256 3151   
Principal Investigator: A. David Mendelow, MD, PhD         
University of Southampton Hospital Recruiting
Southampton, United Kingdom, SO16 6YD
Contact: Belinda Romans    +44 (0) 23 8120 5311   
Contact: Diedrerik Bulters, MD    +44 (0) 23 80777 222 ext 4683   
Principal Investigator: Diederik Bulters, MD         
Sponsors and Collaborators
Daniel Hanley
Genentech, Inc.
Emissary International LLC
Study Chair: Daniel F. Hanley, MD Johns Hopkins University
  More Information

Additional Information:
No publications provided

Responsible Party: Daniel Hanley, MD, Johns Hopkins University Identifier: NCT00784134     History of Changes
Other Study ID Numbers: IVH06
Study First Received: October 31, 2008
Last Updated: September 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
intraventricular hemorrhage thrombolysis

Additional relevant MeSH terms:
Cerebral Hemorrhage
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Vascular Diseases
Tissue Plasminogen Activator
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on November 20, 2014