Clinical Trial on Treatment of Intraventricular Hemorrhage

Completed · Phase 2

Conditions studied: Intraventricular Hemorrhage

In brief

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.

Key facts

Study ID

NCT00650858

Run by

Johns Hopkins University

People needed

52

Starts

2004-02-01

Expected to finish

2008-08-01

Last updated by the study team

2017-12-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• CR Drew Medical Center — Los Angeles, California, United States
• Standford Medical Center — Palo Alto, California, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Via Christi Regional Medical Center — Wichita, Kansas, United States
• University of Maryland Medical Systems — Baltimore, Maryland, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Wayne State University — Detroit, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• St. Louis University — St Louis, Missouri, United States
• Albany Medical Center — Albany, New York, United States
• Mt. Sinai Medical Center — New York, New York, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Temple University — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Baylor College of Medicine — Houston, Texas, United States
• University of Texas HSC, San Antonio — San Antonio, Texas, United States
• University of Virginia, Charlottesville — Charlottesville, Virginia, United States
• INOVA Fairfax Medical Center — Fairfax, Virginia, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Foothills Medical Centre — Calgary, Alberta, Canada
• University of Heidelberg — Heidelberg, Germany
• Newcastle General Hospital — Newcastle upon Tyne, United Kingdom

Full record on ClinicalTrials.gov

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