NCT01064011

Prospective Randomized, Controlled Trial for Treatment of Intraventricular Hemorrhage

A Prospective Randomized, Controlled Trial for Treatment of Intraventricular Hemorrhage: External Ventricular Drainage and Intraventricular Thrombolysis vs. External Ventricular Drainage and Endoscopic Evacuation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Albany Medical College · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Intraventricular Hemorrhage

Interventions

Type	Name	Description
PROCEDURE	Rt-PA thrombolysis	patients will be administered a total of six doses of rt-PA (each 1 mg/ml) through the external ventricular drain every eight hours.
PROCEDURE	endoscopic hematoma evacuation	In the operating room under general anesthesia, the external ventricular drain will be removed and the burr hole enlarged to allow for entry of the endoscope. The neuroscope will be introduced through the burr hole down the prior external ventricular drain tract into the ipsilateral ventricle. utilizing a standard technique combining gentle aspiration, continuous irrigation, and grasping forceps,the intraventricular hematoma will be evacuated. After the evacuation the endoscope will be removed and an external ventricular drain will be reattached to a closed system and permitted to drain post-operatively.

Timeline

• Start date: 2010-01-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2010-02-08
• Last updated: 2011-06-27

Locations

1 site across 1 country: United States