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Prophylactic Urokinase in the Management of Long-Term Venous Access Devices in Children: A Children's Oncology Group Study

From the Department of Surgery, Division of Pediatric Surgery, Penn State College of Medicine, Hershey; Department of Surgery, Children's Hospital of Pittsburgh, Pittsburgh, PA; Department of Pediatrics, Division of Pediatric Hematology/Oncology, Oregon Health Sciences University, Portland, OR; Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, CA; Department of Pediatric Surgery, The Children's Hospital, Denver, CO

Address reprint requests to Peter Dillon, MD, Division of Pediatric Surgery, MC H113, 500 University Dr, Penn State Milton S. Hershey Medical Center, Hershey, PA 17033; e-mail: pdillon1{at}psu.edu CC: smason{at}childrensoncologygroup.org

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.

This study was funded in part by a grant from Abbott Laboratories to the Children's Cancer Group. G.R.J., G.M.H., and H.A.B.-R. served as consultants to Abbott Laboratories. No individuals received direct remuneration from Abbott Laboratories during the conduct of this study.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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