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

This study is currently recruiting participants.
Verified January 2010 by Albany Medical College
Sponsor:
Information provided by:
Albany Medical College
ClinicalTrials.gov Identifier:
NCT01064011
First received: February 5, 2010
Last updated: June 24, 2011
Last verified: January 2010
History of Changes
  Purpose

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.


Condition Intervention
Intraventricular Hemorrhage
 Procedure: Rt-PA thrombolysis
Procedure: endoscopic hematoma evacuation

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

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
Drug Information available for: Alteplase
U.S. FDA Resources

Further study details as provided by Albany Medical College:

Estimated Enrollment: 34
Study Start Date: January 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 >1.5. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01064011

Contacts
Contact: Yu-Hung Kuo, MD 518 262-5088 kuoy@mail.amc.edu
Contact: Tyler Kenning, MD 518 262-5088 kennint@mail.amc.edu

Locations
United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Yu-Hung Kuo, MD     518-262-5088     kuo@mail.amc.edu    
Contact: Tyler Kenning, MD     518 262-5088     kennint@mail.amc.edu    
Sponsors and Collaborators
Albany Medical College
  More Information

No publications provided

Responsible Party: Yu-hung Kuo, MD, Albany Medical College
ClinicalTrials.gov Identifier: NCT01064011     History of Changes
Other Study ID Numbers: 01
Study First Received: February 5, 2010
Last Updated: June 24, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hemorrhage
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013