Phase II Clinical Trial on Treatment of Intraventricular Hemorrhage
Information source: Johns Hopkins University
Information obtained from ClinicalTrials.gov on November 03, 2008
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: Recruiting
Sponsored by: Johns Hopkins University Official(s) and/or principal investigator(s):
Daniel F Hanley, MD, Study Chair, Affiliation: Johns Hopkins University
Overall contact:
Karen Lane, CMA, CCRP, Phone: 410-614-3461, Email: klane@jhmi.edu
Summary
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.
Clinical Details
Official title: Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage (IVH)
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: 1.) 30-day mortality.
2.) Incidence of ventriculitis, meningitis.
3.) Rate of 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
Karen Lane, CMA, CCRP, Phone: 410-614-3461, Email: klane@jhmi.edu
Johns Hopkins University, Baltimore, Maryland 21287, United States; Recruiting
Shannon Le Droux, Phone: 410-502-0505, Email: sledrou1@jhmi.edu
Judy Huang, MD, Sub-Investigator
University of Maryland Medical Systems, Baltimore, Maryland 21202, United States; Recruiting
Charlene Aldrich, RN, Phone: 410-328-5332, Email: CALDRICH@smail.umaryland.edu
E. Francois Aldrich, MD, Principal Investigator
Wayne State University, Detroit, Michigan 48201, United States; Recruiting
Elizabeth Berlow
William Coplin, MD, Principal Investigator
Robert Johnson, MD, Principal Investigator
Mt. Sinai Medical Center, New York, New York 10029, United States; Recruiting
Emiliano Tatti, MD
Joshua Bederson, MD, Principal Investigator
University of Cincinnati, Cincinnati, Ohio 45267, United States; Recruiting
Marlena Robinson
Mario Zuccarello, MD, Principal Investigator
Medical University of South Carolina, Charleston, South Carolina 29425, United States; Recruiting
Marc Lapointe
Bonnie Muntz-Pope
Byron Bailey, MD, Principal Investigator
Marc Lapointe, PharmD, Sub-Investigator
Virginia Commonwealth University, Richmond, Virginia 23298, United States; Recruiting
Randall Merchant, PhD, Phone: 804-828-9528, Email: rmerchan@hsc.vcu.edu
William Broaddus, MD, Principal Investigator
Additional Information
CLEAR IVH Website
Starting date: November 1999
Ending date: June 2010
Last updated: May 9, 2008
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