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


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.


CONCLUSIONS
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.
Dillon
Peter W
PW
Department of Surgery, Division of Pediatric Surgery, Penn State College of Medicine, Hershey, PA 17033, USA. pdillon1@psu.edu
Jones
Gary R
GR
Bagnall-Reeb
Holly A
HA
Buckley
Jonathon D
JD
Wiener
Eugene S
ES
Haase
Gerald M
GM
D000293:Adolescent; D000328:Adult; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D002405:Catheterization, Central Venous / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D017053:Infection Control; D008297:Male; D009369:Neoplasms / Q000188:drug therapy; D010960:Plasminogen Activators / Q000008:administration & dosage / Q000627:therapeutic use*; D013927:Thrombosis / Q000517:prevention & control*; D014568:Urokinase-Type Plasminogen Activator / Q000008:administration & dosage / Q000627:therapeutic use*
D000970:Antineoplastic Agents; D010960:Plasminogen Activators; D014568:Urokinase-Type Plasminogen Activator