| A Phase III, Open-label, Single-arm Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters. | |
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MedLine Citation:
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PMID: 21570873 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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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. |
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Authors:
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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:
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Type: JOURNAL ARTICLE Date: 2011-5-12 |
Journal Detail:
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Title: Journal of vascular and interventional radiology : JVIR Volume: - ISSN: 1535-7732 ISO Abbreviation: - Publication Date: 2011 May |
Date Detail:
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Created Date: 2011-5-16 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9203369 Medline TA: J Vasc Interv Radiol Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
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Copyright © 2011 SIR. Published by Elsevier Inc. All rights reserved. |
Affiliation:
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Division of Pediatric Hematology/Oncology, University of South Florida and Tampa General Hospital, 1 Tampa General Circle, Tampa, FL 33606. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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