Prospective Randomized, Controlled Trial for Treatment of Intraventricular Hemorrhage (IVH)

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

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.

Study Overview

• Status: Unknown
• Conditions: Intraventricular Hemorrhage
• Intervention / Treatment: Procedure: Rt-PA thrombolysis; Procedure: endoscopic hematoma evacuation

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Albany, New York, United States, 12208
      • Recruiting
      • Albany Medical Center
      • Contact: Tyler Kenning, MD; Phone Number: 518 262-5088; Email: kennint@mail.amc.edu
      • Contact: Yu-Hung Kuo, MD; Phone Number: 518-262-5088; Email: kuo@mail.amc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: External Ventricular drainage, Intraventricular Thrombolysis	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.
OTHER: External Ventricular Drainage and Endoscopic Evacuation	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.

Collaborators and Investigators

• Sponsor: Albany Medical College

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ANTICIPATED): January 1, 2014
• Study Completion (ANTICIPATED): January 1, 2014

Study Registration Dates

• First Submitted: February 5, 2010
• First Submitted That Met QC Criteria: February 5, 2010
• First Posted (ESTIMATE): February 8, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): June 27, 2011
• Last Update Submitted That Met QC Criteria: June 24, 2011
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: 01 (Miami VAHS)