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Abstracts: ASAIO Bioengineering/tissue Engineering Abstracts

ANTITHROMBOTIC AND ANTIMICROBIAL PROPERTIES OF END-POINT ATTACHED HEPARIN ON IMPLANTABLE PORT CATHETERS; A CLINICAL TRIAL IN CHILDREN WITH MALIGNANT DISEASE

Holmer, Erik1; Soderhall, Stefan2

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A major problem with the use of intravascular catheters is thrombotic deposition causing catheter occlusion. Another important problem is infection. Thrombotic deposits are likely to enhance microbial colonisation. Heparin coating of medical devices using end-point covalent bonding (Carmeda BioActive Surface, CBAS) has demonstrated to reduce thrombotic deposits both in vitro and in vivo. The purpose of this study is to evaluate the ability of CBAS to reduce thrombotic and bacteraemic events on implanted long-term catheters in a clinical setting. A prospective, randomised, double blind, parallel study in children with malignant diseases requiring a port catheter was designed. Children were randomised to receive a CBAS-coated or an identical non coated polyurethane catheter. Catheter thrombosis and infection were assessed during a period of 3 months. If occlusion of the catheter occured, t-PA was injected into the catheter. Initiation of t-PA treatment was defined as end point for catheter thrombosis. Diagnosis of bloodstream infection was done according to definitions given by the hospital. The study is finalised and has enrolled 143 subjects. The frequency of catheter thrombosis and bloodstream infection in the entire study population is 31% and 34%, respectively. A strong association between thrombosis and infection was found. The presentation will include unblinded results for the two study arms.

Copyright © 2005 by the American Society for Artificial Internal Organs