Prospective Randomized, Controlled Trial for Treatment of Intraventricular Hemorrhage

Intraventricular Hemorrhage Clinical Trial

— IVH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01064011
• Other study ID #: 01
• Status: Recruiting
• Phase: N/A
• First received: February 5, 2010
• Last updated: June 24, 2011
• Start date: January 2010
• Est. completion date: January 2014

Study information

• Verified date: January 2010
• Source: Albany Medical College
• Contact: Yu-Hung Kuo, MD
• Phone: 518 262-5088
• Email: kuoy[@]mail.amc.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 >1.5. 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intraventricular Hemorrhage

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albany Medical College

Country where clinical trial is conducted

United States,