A Prospective Randomized, Controlled Trial for Treatment of Intraventricular Hemorrhage: External Ventricular Drainage and Intraventricular Thrombolysis vs. External Ventricular Drainage and Endoscopic Evacuation
| City: |
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Albany |
| State: |
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New York |
| Zip Code: |
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12208 |
| Conditions: |
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Intraventricular Hemorrhage |
| Purpose: |
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Intraventricular hemorrhage comprises about 15% of the 500,000 strokes that occur annually
in the United States. In the emergent setting, patients with obstructive hydrocephalus are
routinely treated with placement of an external ventricular drain. This study will compare
the effect of external ventricular drainage plus intraventricular thrombolysis versus
external ventricular drainage plus endoscopic evacuation on neurologic outcomes for patients
with hydrocephalus from intraventricular hemorrhage.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Age 18-75
- Radiographic evidence of intraventricular hemorrhage with hydrocephalus
- Admission Glasgow Coma Scale ≥ 5 (motor score ≥ 2)
- Placement of an external ventricular drain with an opening pressure >20 mm Hg
Exclusion Criteria:
- Intraventricular hemorrhage secondary to cerebral aneurysm, arteriovenous
malformation, or tumor
- Coagulopathy (Platelet count <100,000, International normalized ratio >1.5. Reversal
of warfarin is permitted.)
- Age <18 or >75
- Pregnancy (positive pregnancy test)
- Clotting disorders
- Medical contraindications to administration of general anesthesia as determined by
the attending anesthesiologist
- Medical contraindications to surgery as determined by the attending neurosurgeon
- Contraindication to recombinant tissue plasminogen activator administration:
- Evidence of enlargening intracranial hemorrhage as evidenced by an increase in
intracranial hemorrhage volume (>5 ml) on CT obtained after EVD placement
- Internal bleeding, involving retroperitoneal sites, or the gastrointestinal,
genitourinary, or respiratory tracts
- Superficial or surface bleeding, observed at vascular puncture and access sites
(e.g. venous cutdowns, arterial punctures) or site of recent surgical
intervention
- Evidence of cerebrospinal infection by Gram stain or culture
- Advanced directive indicating Do Not Resuscitate or Do Not Intubate status
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| NCT ID: |
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NCT01064011 |
| Primary Contact: |
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Yu-Hung Kuo, MD
Phone: 518 262-5088
Email: kuoy@mail.amc.edu
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| Backup Contact: |
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Email: kennint@mail.amc.edu
Tyler Kenning, MD
Phone: 518 262-5088
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| Location Contact: |
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Albany, New York 12208
United States
Yu-Hung Kuo, MD
Phone: 518-262-5088
Email: kuo@mail.amc.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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