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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01064011
Recruitment Status : Unknown
Verified January 2010 by Albany Medical College.
Recruitment status was:  Recruiting
First Posted : February 8, 2010
Last Update Posted : June 27, 2011
Information provided by:
Albany Medical College

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.

Condition or disease Intervention/treatment Phase
Intraventricular Hemorrhage Procedure: Rt-PA thrombolysis Procedure: endoscopic hematoma evacuation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : January 2010
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Endoscopy

Arm Intervention/treatment
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.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01064011

Contact: Yu-Hung Kuo, MD 518 262-5088
Contact: Tyler Kenning, MD 518 262-5088

United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Yu-Hung Kuo, MD    518-262-5088   
Contact: Tyler Kenning, MD    518 262-5088   
Sponsors and Collaborators
Albany Medical College

Responsible Party: Yu-hung Kuo, MD, Albany Medical College Identifier: NCT01064011     History of Changes
Other Study ID Numbers: 01
First Posted: February 8, 2010    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: January 2010

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