Preliminary report of the clot lysis evaluating accelerated resolution of intraventricular hemorrhage (CLEAR-IVH) clinical trial

  • T. Morgan
  • I. Awad
  • P. Keyl
  • K. Lane
  • D. Hanley
Part of the Acta Neurochirurgica Supplementum book series (NEUROCHIRURGICA, volume 105)

Abstract

Introduction

Brain hemorrhage is the most frequent fatal form of stroke and has the highest level of morbidity of any stroke subtype. For patients with both intracerebral hemorrhage and intraventricular hemorrhage (IVH), expected mortality is 50-80%. No validated, efficacious treatment exists for humans, but animal models demonstrate substantial physiologic and functional benefits associated with rapid, near-complete removal of blood from either the ventricle or intracerebral location (i.e., ~80% removal over 48 h). The purpose of the CLEAR-IVH trial (Parts A and B) is to evaluate safety and efficacy of using multiple injections of low-dose rt-PA to accelerate lysis and evacuation of IVH.

Methods

Patients enrolled in the trial receive an injection of 1.0mg rt-PA through an external ventricular drain every 8 h up to 12 doses, or until clot reduction or clinical endpoint is met. CT scans are taken daily to monitor clot resolution and check for unexpected bleeding events. In a previous dose-finding study where the safety profile (symptomatic re-bleeding) was 0%, 1 mg rt-PA every 8 h was determined the appropriate dose.

Results

Comprehensive analyses of 36 patients in the recently completed CLEAR-IVH Part B are currently being conducted. Adverse events are within safety limits, including 30-day mortality, 8%; symptomatic re-bleeding, 8%; and bacterial ventriculitis, 0%.

Conclusion

Preliminary analyses show that use of low-dose rt-PA can be safely administered to stable IVH clots and may increase lysis rates.

Keywords

Intraventricular hemorrhage thrombolysis tissue plas-minogen activator. 

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Copyright information

© Springer-Verlag 2008

Authors and Affiliations

  • T. Morgan
    • 1
  • I. Awad
    • 2
  • P. Keyl
    • 3
  • K. Lane
    • 1
  • D. Hanley
    • 1
  1. 1.The Johns Hopkins UniversityBaltimoreUSA
  2. 2.Evanston Northwestern UniversityEvanstonUSA
  3. 3.Keyl AssociatesEast SandwichUSA

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