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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Albany Medical College.
Recruitment status was  Recruiting
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

February 5, 2010
June 24, 2011
January 2010
January 2014   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01064011 on ClinicalTrials.gov Archive Site
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Prospective Randomized, Controlled Trial for Treatment of Intraventricular Hemorrhage
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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Intraventricular Hemorrhage
  • 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.
  • 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.
  • External Ventricular drainage, Intraventricular Thrombolysis
    Intervention: Procedure: Rt-PA thrombolysis
  • External Ventricular Drainage and Endoscopic Evacuation
    Intervention: Procedure: endoscopic hematoma evacuation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
34
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Yu-Hung Kuo, MD 518 262-5088 kuoy@mail.amc.edu
Contact: Tyler Kenning, MD 518 262-5088 kennint@mail.amc.edu
United States
 
NCT01064011
01
No
Yu-hung Kuo, MD, Albany Medical College
Albany Medical College
Not Provided
Not Provided
Albany Medical College
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP