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Clinical Trial on Treatment of Intraventricular Hemorrhage

Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Intraventricular Hemorrhage

Intervention: tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Johns Hopkins University

Official(s) and/or principal investigator(s):
Daniel F Hanley, MD, Study Chair, Affiliation: Johns Hopkins University

Summary

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

Clinical Details

Official title: Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage (IVH)

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

30-day Mortality

Incidence of Bacterial Ventriculitis, Meningitis

Rate of Symptomatic Bleeding Events

Secondary outcome:

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).

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

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Age 18-75 2. IVC placed as standard of care using less than or equal to 2 complete passes. 3. Spontaneous ICH less than or equal to 30 cc. 4. 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). 5. 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). 6. ON stability CT scan either the 3rd or 4th ventricles are occluded with blood (no evidence of CSF flow on CT). 7. SBP < 200 mmHg sustained for 6 hours. 8. Historical Rankin of 0 or 1. Exclusion Criteria: 1. Suspected or untreated aneurysm or AVM (unless ruled out by angiogram or MRA/MRI). 2. Clotting disorders. 3. Patients with platelet count < 100,000, INR > 1. 7, PT > 15s, or an elevated APTT. 4. Pregnancy (positive pregnancy test). 5. Infratentorial hemorrhage (i. e., parenchymal/posterior fossa hematoma; all cerebellar hematomas excluded). 6. 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). 7. ICH enlargement during the 6-hour stabilization period (6 hour after IVC placement). 8. Internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts. 9. Superficial or surface bleeding, observed mainly at vascular puncture and access sites (e. g., venous cutdowns, arterial punctures) or site of recent surgical intervention. 10. Known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, and subacute bacterial endocarditis. 11. Prior enrollment in the study. 12. Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated. 13. Participation in another simultaneous medical investigation or trial.

Locations and Contacts

University of Heidelberg, Heidelberg 69120, Germany

Newcastle General Hospital, Newcastle upon Tyne NE4 6BE, United Kingdom

University of Alabama at Birmingham, Birmingham, Alabama 35294, United States

Foothills Medical Centre, Calgary, Alberta T2N 2T9, Canada

CR Drew Medical Center, Los Angeles, California 90059, United States

Standford Medical Center, Palo Alto, California 94394, United States

Hartford Hospital, Hartford, Connecticut 06102, United States

Loyola University Medical Center, Maywood, Illinois 60153, United States

Via Christi Regional Medical Center, Wichita, Kansas 67214, United States

Johns Hopkins University, Baltimore, Maryland 21287, United States

University of Maryland Medical Systems, Baltimore, Maryland 21202, United States

Henry Ford Hospital, Detroit, Michigan 48202, United States

Wayne State University, Detroit, Michigan 48201, United States

St. Louis University, St. Louis, Missouri 63110, United States

Albany Medical Center, Albany, New York 12208, United States

Mt. Sinai Medical Center, New York, New York 10029, United States

University of Cincinnati, Cincinnati, Ohio 45267, United States

Temple University, Philadelphia, Pennsylvania 19140, United States

Medical University of South Carolina, Charleston, South Carolina 29425, United States

Baylor College of Medicine, Houston, Texas 77030, United States

University of Texas HSC, San Antonio, San Antonio, Texas 78229, United States

University of Virginia, Charlottesville, Charlottesville, Virginia 22908, United States

INOVA Fairfax Medical Center, Fairfax, Virginia 22042, United States

Virginia Commonwealth University, Richmond, Virginia 23298, United States

Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States

Additional Information

CLEAR III Website

Starting date: February 2004
Last updated: June 13, 2012

Page last updated: August 20, 2015

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