Prophylactic urokinase in the management of long-term venous access devices in children: a Children's Oncology Group study

J Clin Oncol. 2004 Jul 1;22(13):2718-23. doi: 10.1200/JCO.2004.07.019.

Abstract

Purpose: Infection and thrombosis are serious complications of long-term vascular access devices in children undergoing chemotherapy. Since routine fibrinolytic therapy may decrease these complications, the purpose of this study was to compare the efficacy of an every-2-week administration of urokinase with standard heparin flushes in reducing the incidence of device-related infections and occlusions.

Materials and methods: This study was a prospective, randomized phase III multicenter trial conducted by the Children's Cancer Group, in which patients with implantable ports or tunneled catheters received either urokinase or heparin every 2 weeks for 12 months. Study end points were time to first occlusion or time to first device-related infection.

Results: Five hundred seventy-seven patients from 29 institutions were enrolled, of whom 51% had external catheters and 49% had ports. Urokinase administration resulted in fewer occlusive events than heparin (23% v 31%; P =.02), a longer time to first occlusive event (log-rank analysis, P =.006), and a 1.6-fold difference in the rate of occlusive events (Poisson regression, P =.003). Similar results were noted when comparing ports and tunneled catheters. The urokinase group also had a 1.4-fold difference in the rate of infection (Poisson regression, P =.05) and longer time to first infection (log-rank, P =.07), but the difference was significant only in tunneled catheters.

Conclusion: Urokinase administration every 2 weeks significantly affects the rate of occlusive events in ports and tunneled catheters and of infectious events in external catheters compared with heparin administration.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Antineoplastic Agents / administration & dosage*
  • Catheterization, Central Venous / adverse effects*
  • Child
  • Child, Preschool
  • Female
  • Humans
  • Infant
  • Infant, Newborn
  • Infection Control
  • Male
  • Neoplasms / drug therapy
  • Plasminogen Activators / administration & dosage
  • Plasminogen Activators / therapeutic use*
  • Thrombosis / prevention & control*
  • Urokinase-Type Plasminogen Activator / administration & dosage
  • Urokinase-Type Plasminogen Activator / therapeutic use*

Substances

  • Antineoplastic Agents
  • Plasminogen Activators
  • Urokinase-Type Plasminogen Activator