title: A phase III, open-label, single-arm study of tenecteplase for restoration of function in dysfunctional central venous catheters.
abstract: OBJECTIVE
  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).
  
  
  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.affiliation: Division of Pediatric Hematology/Oncology, University of South Florida and Tampa General Hospital, 1 Tampa General Circle, Tampa, FL 33606, USA. ctebbi@aol.com
authors.forename: Cameron
authors.initials: C
authors.lastname: Tebbi
authors.forename: John
authors.initials: J
authors.lastname: Costanzi
authors.forename: Robert
authors.initials: R
authors.lastname: Shulman
authors.forename: Luke
authors.initials: L
authors.lastname: Dreisbach
authors.forename: Brian R
authors.initials: BR
authors.lastname: Jacobs
authors.forename: Martha
authors.initials: M
authors.lastname: Blaney
authors.forename: Mark
authors.initials: M
authors.lastname: Ashby
authors.forename: Barbara S
authors.initials: BS
authors.lastname: Gillespie
authors.forename: Susan M
authors.initials: SM
authors.lastname: Begelman
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002405:Catheterization, Central Venous / Q000009:adverse effects*; D002408:Catheters, Indwelling; D002648:Child; D002675:Child, Preschool; D004868:Equipment Failure; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage*; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D000077785:Tenecteplase; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator; D000077785:Tenecteplase