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A Phase III, Open-label, Single-arm Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters.
MedLine Citation:
PMID:  21570873     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
PURPOSE: To evaluate, in a phase III, single-arm study, the safety and efficacy of the thrombolytic agent tenecteplase in restoring function to dysfunctional central venous catheters (CVCs). MATERIALS AND METHODS: Pediatric and adult patients with dysfunctional CVCs were eligible to receive as much as 2 mL (2 mg) of intraluminal tenecteplase, which was left to dwell in the CVC lumen for a maximum of 120 minutes. If CVC function was not restored at 120 minutes, a second dose was instilled for an additional 120 minutes. RESULTS: Tenecteplase was administered to 246 patients. Mean patient age was 44 years (range, 0-92 y); 72 patients (29%) were younger than 17 years of age. Chemotherapy was the most common reason for catheter insertion. Restoration of CVC function was achieved in 177 patients (72%) within 120 minutes after the first dose. After instillation of a maximum of two doses of tenecteplase, CVC function was restored in 200 patients (81%), with similar frequencies in pediatric (83%) and adult (80%) patients. Adverse events (AEs) were reported in 31 patients (13%); fever (2%), neutropenia (1%), and nausea (0.8%) were most common. One serious AE, an allergic hypersensitivity reaction, was judged to be related to tenecteplase and/or a chemotherapeutic agent that the patient was receiving concurrently. CONCLUSIONS: Consecutive administration of one or two doses of tenecteplase into CVCs showed efficacy in the restoration of catheter function in patients with dysfunctional CVCs.
Authors:
Cameron Tebbi; John Costanzi; Robert Shulman; Luke Dreisbach; Brian R Jacobs; Martha Blaney; Mark Ashby; Barbara S Gillespie; Susan M Begelman
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-5-12
Journal Detail:
Title:  Journal of vascular and interventional radiology : JVIR     Volume:  -     ISSN:  1535-7732     ISO Abbreviation:  -     Publication Date:  2011 May 
Date Detail:
Created Date:  2011-5-16     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9203369     Medline TA:  J Vasc Interv Radiol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2011 SIR. Published by Elsevier Inc. All rights reserved.
Affiliation:
Division of Pediatric Hematology/Oncology, University of South Florida and Tampa General Hospital, 1 Tampa General Circle, Tampa, FL 33606.
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