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J Vasc Interv Radiol · Aug 2011
A phase III, open-label, single-arm study of tenecteplase for restoration of function in dysfunctional central venous catheters.
- Cameron Tebbi, John Costanzi, Robert Shulman, Luke Dreisbach, Brian R Jacobs, Martha Blaney, Mark Ashby, Barbara S Gillespie, and Susan M Begelman.
- Division of Pediatric Hematology/Oncology, University of South Florida and Tampa General Hospital, 1 Tampa General Circle, Tampa, FL 33606, USA. ctebbi@aol.com
- J Vasc Interv Radiol. 2011 Aug 1; 22 (8): 1117-23.
PurposeTo 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 MethodsPediatric 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.ResultsTenecteplase 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.ConclusionsConsecutive administration of one or two doses of tenecteplase into CVCs showed efficacy in the restoration of catheter function in patients with dysfunctional CVCs.Copyright © 2011 SIR. Published by Elsevier Inc. All rights reserved.
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