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Prospective Randomized, Controlled Trial for Treatment of Intraventricular Hemorrhage

NCT01064011 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2011-06-27

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Albany Medical College

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01064011 on ClinicalTrials.gov