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

Albany Medical College1 site in 1 country34 target enrollmentJanuary 2010

ConditionsIntraventricular Hemorrhage

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Intraventricular Hemorrhage
Sponsor: Albany Medical College
Enrollment: 34
Locations: 1
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 2010

End Date

January 2014

Last Updated

14 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Albany Medical College

Eligibility Criteria

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.
•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