Prospective Randomized, Controlled Trial for Treatment of Intraventricular Hemorrhage

NCT01064011 | Unknown

• 1 other identifier: 01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraventricular Hemorrhage

Study Arms (2)

External Ventricular drainage, Intraventricular Thrombolysis

OTHER

Procedure: Rt-PA thrombolysis

External Ventricular Drainage and Endoscopic Evacuation

OTHER

Procedure: endoscopic hematoma evacuation

Interventions

Rt-PA thrombolysis PROCEDURE

patients will be administered a total of six doses of rt-PA (each 1 mg/ml) through the external ventricular drain every eight hours.

External Ventricular drainage, Intraventricular Thrombolysis

endoscopic hematoma evacuation PROCEDURE

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.

External Ventricular Drainage and Endoscopic Evacuation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Albany Medical College: lead

Study Sites (1)

Albany Medical Center

Albany, New York, 12208, United States

RECRUITING

Central Study Contacts

Yu-Hung Kuo, MD

CONTACT

518 262-5088; kuoy@mail.amc.edu

Tyler Kenning, MD

CONTACT

518 262-5088; kennint@mail.amc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 5, 2010
• First Posted: February 8, 2010
• Study Start: January 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: June 27, 2011

Record last verified: 2010-01

Locations

US (1)