Recruiting

External Ventricular Drainage & Intraventricular Thrombolysis

Sponsor:

Albany Medical College

Code:

NCT01064011

Conditions

Intraventricular Hemorrhage

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Rt-PA thrombolysis

endoscopic hematoma evacuation

Study Details

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.

Conditions

Intraventricular Hemorrhage

Study ID

NCT01064011

Start date

Jan, 2010

Status verified date

Jan, 2010

Completion date

Jan, 2014

Anticipated

Primary completion date

Jan, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: External Ventricular drainage, Intraventricular Thrombolysis

other: External Ventricular Drainage and Endoscopic Evacuation

Interventions

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.

Central Contacts and Locations

Central contacts

Yu-Hung Kuo, MD

518 262-5088kuoy@mail.amc.edu

Tyler Kenning, MD

518 262-5088kennint@mail.amc.edu

Locations

Albany Medical Center

Recruiting

Albany, New York, United States, 12208

Contacts

Yu-Hung Kuo, MD

518-262-5088kuo@mail.amc.edu

Tyler Kenning, MD

518 262-5088kennint@mail.amc.edu

More Information

Sponsor

Albany Medical College

Last update posted

Jun 27, 2011

Last verified

Jan, 2010

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Albany Medical College on 2011-06-27.