title: Tenecteplase for the improvement of blood flow rate in dysfunctional hemodialysis catheters.
abstract: BACKGROUND
  We evaluated the efficacy and safety of the thrombolytic agent tenecteplase for the treatment of dysfunctional hemodialysis (HD) catheters.
  
  
  METHODS
  Data were pooled from 2 Phase III clinical studies: the randomized, placebo-controlled TROPICS 3 trial and the open-label TROPICS 4 trial. Eligible patients received either an initial dose of tenecteplase (2 mg/lumen) or placebo (TROPICS 3 only) for a 1-h intracatheter dwell. Treatment success was defined as blood flow rate (BFR) ≥ 300 ml/min and a ≥ 25 ml/min increase from baseline BFR, without line reversal, 30 min before and at the end of HD. All TROPICS 4 patients and the TROPICS 3 patients enrolled after the final protocol amendment without treatment success received an instillation of tenecteplase at the end of the initial visit for an extended dwell of up to 72 h.
  
  
  RESULTS
  A total of 372 patients with dysfunctional catheters were enrolled in the 2 studies. Of the 297 patients treated with tenecteplase at the initial visit, 31% achieved treatment success, with a mean (SD) change from baseline BFR of 73 (120) ml/min. Among the 179 patients who received a 1-h dwell of study drug followed by extended-dwell tenecteplase, 46% had treatment success at the end of the next HD session. Six catheter-related bloodstream infections and 2 thromboses were reported in patients following tenecteplase exposure.
  
  
  CONCLUSIONS
  Tenecteplase, administered as a 1-h dwell or a 1-h dwell followed by an extended dwell, was associated with improved BFR in dysfunctional HD catheters in the TROPICS 3 and 4 clinical trials.
authors.affiliation: Temple University, Philadelphia, PA, USA. Goldman1@Temple.edu
authors.forename: Jesse
authors.initials: J
authors.lastname: Goldman
authors.forename: Steven
authors.initials: S
authors.lastname: Fishbane
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Oliver
authors.forename: Martha
authors.initials: M
authors.lastname: Blaney
authors.forename: Joan R
authors.initials: JR
authors.lastname: Jacobs
authors.forename: Susan M
authors.initials: SM
authors.lastname: Begelman
mesh_terms: D000368:Aged; D017326:Clinical Trials, Phase III as Topic / Q000706:statistics & numerical data; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006083:Graft Occlusion, Vascular / Q000517:prevention & control*; D006801:Humans; D007676:Kidney Failure, Chronic / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D012039:Regional Blood Flow / Q000187:drug effects*; D006435:Renal Dialysis; D000077785:Tenecteplase; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator; D000077785:Tenecteplase