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

Albany Medical College

Status: Unknown

Conditions: Intraventricular Hemorrhage

Treatments: Procedure: endoscopic hematoma evacuation; Procedure: Rt-PA thrombolysis

Study type: Interventional

Funder types: Other

Identifiers

NCT01064011

01

Details and patient eligibility

About

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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

External Ventricular drainage, Intraventricular Thrombolysis

Other group

Treatment:

Procedure: Rt-PA thrombolysis

External Ventricular Drainage and Endoscopic Evacuation

Other group

Treatment:

Procedure: endoscopic hematoma evacuation