Phase II Clinical Trial on Treatment of Intraventricular Hemorrhage - Full Text View

Sponsors and Collaborators:	Johns Hopkins University FDA Office of Orphan Products Development Genentech
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00650858

Purpose

The specific objective of this trial is to determine the lowest dose possible with the best pharmacokinetic and safety profile and it's ability to remove a blood clot from the ventricular system.

Condition	Intervention	Phase
Intraventricular Hemorrhage	Drug: tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo)	Phase II

Drug Information available for: Alteplase Tissue-type plasminogen activator

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage (IVH)

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

1.) 30-day mortality. 2.) Incidence of ventriculitis, meningitis. 3.) Rate of bleeding events. [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

1.) Rate of clot size reduction at Days 4-5 determined by CT scans (stages 1 and 2). 2.) 90 and 180 -day GOS< Rankin, Stroke Impact Scale (stage 2 only). [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	36
Study Start Date:	November 1999
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Stage 1: Subjects received intraventricular injections of either 0.3 mg or 1.0 mg of rt-PA every 12 hours for up to 8 doses.

Stage 2: Subjects will receive 1.0 mg every 4, 6 or 8 hours depending on the dose tier open at the time of enrollment.

Detailed Description:

The purpose of this trial is to determine the efficacy and pharmacokinetics of intraventricular injections of multiple low doses of rt-PA. Sixteen subjects were already randomized to receive intraventricular injections of with 0.3 mg or 1.0 mg of rt-PA every 12 hours for up to 8 doses. Results of this stage (n=16) were then analyzed and the most effective dose of 1.0 mg was chosen to be used in the second stage (n=36) to determine the optimal frequency of dosing. We propose to test if this intervention facilitates more rapid clot resolution, complete recovery function and decreased mortality from this condition.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18-75
IVC placed as standard of care using less than or equal to 2 complete passes.
Spontaneous ICH less than or equal to 30 cc.
Able to receive first dose within 48 hours of CT scan diagnosing IVH (providing the time of symptom onset to diagnostic CT does not exceed 12 hours).
Clot size measured on CT scan done 6 hours after IVC placement must be equal to the presentation clot size plus or minus 5 cc (as determined by the AxBxC)/2 method).
ON stability CT scan either the 3rd or 4th ventricles are occluded with blood (no evidence of CSF flow on CT).
SBP < 200 mmHg sustained for 6 hours.
Historical Rankin of 0 or 1.

Exclusion Criteria:

Suspected or untreated aneurysm or AVM (unless ruled out by angiogram or MRA/MRI).
Clotting disorders.
Patients with platelet count < 100,000, INR > 1.7, PT > 15s, or an elevated APTT.
Pregnancy (positive pregnancy test).
Infratentorial hemorrhage (i.e., parenchymal/posterior fossa hematoma; all cerebellar hematomas excluded).
SAH (An angiogram should be obtained when the diagnostic CT scan demonstrates subarachnoid hemorrhage or any hematoma location or appearance not strongly associated with hypertension. If the angiogram does not demonstrate a bleeding source that accounts for the hemorrhage, the patient is eligible for the study).
ICH enlargement during the 6-hour stabilization period (6 hour after IVC placement).
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) or site of recent surgical intervention.
Known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, and subacute bacterial endocarditis.
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 medical investigation or trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650858

Contacts

Contact: Karen Lane, CMA, CCRP

410-614-3461

klane@jhmi.edu

Locations

United States, Maryland
Johns Hopkins University	Recruiting
Baltimore, Maryland, United States, 21287
Contact: Shannon Le Droux 410-502-0505 sledrou1@jhmi.edu
Sub-Investigator: Judy Huang, MD
University of Maryland Medical Systems	Recruiting
Baltimore, Maryland, United States, 21202
Contact: Charlene Aldrich, RN 410-328-5332 CALDRICH@smail.umaryland.edu
Principal Investigator: E. Francois Aldrich, MD
United States, Michigan
Wayne State University	Recruiting
Detroit, Michigan, United States, 48201
Contact: Elizabeth Berlow
Principal Investigator: William Coplin, MD
Principal Investigator: Robert Johnson, MD
United States, New York
Mt. Sinai Medical Center	Recruiting
New York, New York, United States, 10029
Contact: Emiliano Tatti, MD
Principal Investigator: Joshua Bederson, MD
United States, Ohio
University of Cincinnati	Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Marlena Robinson
Principal Investigator: Mario Zuccarello, MD
United States, South Carolina
Medical University of South Carolina	Recruiting
Charleston, South Carolina, United States, 29425
Contact: Marc Lapointe
Contact: Bonnie Muntz-Pope
Principal Investigator: Byron Bailey, MD
Sub-Investigator: Marc Lapointe, PharmD
United States, Virginia
Virginia Commonwealth University	Recruiting
Richmond, Virginia, United States, 23298
Contact: Randall Merchant, PhD 804-828-9528 rmerchan@hsc.vcu.edu
Principal Investigator: William Broaddus, MD

Sponsors and Collaborators

Johns Hopkins University

FDA Office of Orphan Products Development

Genentech

Investigators

Study Chair:

Daniel F Hanley, MD

Johns Hopkins University

More Information

CLEAR IVH Website This link exits the ClinicalTrials.gov site

Responsible Party:	Johns Hopkins University ( Daniel F. Hanley, M.D. )
Study ID Numbers:	IVH05, ISRCTN47341677
Study First Received:	December 26, 2007
Last Updated:	May 9, 2008
ClinicalTrials.gov Identifier:	NCT00650858
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:

Intraventricular hemorrhage (IVH)
rt-PA

Study placed in the following topic categories:

Cerebral Hemorrhage
Vascular Diseases
Tissue Plasminogen Activator
Central Nervous System Diseases
Intracranial Hemorrhages

Brain Diseases
Hemorrhage
Plasminogen
Cerebrovascular Disorders

Additional relevant MeSH terms:

Fibrin Modulating Agents
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents

Nervous System Diseases
Fibrinolytic Agents
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009