Prospective Randomized, Controlled Trial for Treatment of Intraventricular Hemorrhage

Not Applicable

• Conditions: Intraventricular Hemorrhage
• Interventions: Procedure: Rt-PA thrombolysis; Procedure: endoscopic hematoma evacuation

• Registration Number: NCT01064011
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-01
• Study Start: 2010-01
• Study First Submitted: 2010-02-05
• Study First Submitted QC: 2010-02-05
• Study First Posted: 2010-02-08
• Last Update Submitted: 2011-06-24
• Last Update Posted: 2011-06-27
• Primary Completion: 2014-01
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 34

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
External Ventricular drainage, Intraventricular Thrombolysis	Rt-PA thrombolysis	-
External Ventricular Drainage and Endoscopic Evacuation	endoscopic hematoma evacuation	-

Trial Locations

Locations (1)

Albany Medical Center; 🇺🇸 Albany, New York, United States