Prospective Randomized, Controlled Trial for Treatment of Intraventricular Hemorrhage
Status unconfirmed · Not applicable
Conditions studied: Intraventricular Hemorrhage
In brief
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.
Key facts
- Study ID
- NCT01064011
- Run by
- Albany Medical College
- People needed
- 34
- Starts
- 2010-01-01
- Expected to finish
- 2014-01-01
- Last updated by the study team
- 2011-06-27
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Albany Medical Center — Albany, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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