title: Safe and cost effective use of alteplase for the clearance of occluded central venous access devices.
abstract: OBJECTIVE
  To determine whether cryopreserved solutions of the thrombolytic agent alteplase could be used as a safe, effective, and economically reasonable alternative to urokinase in patients presenting with occluded central venous access devices (CVADs).
  
  
  METHODS
  Alteplase has been reported as an efficacious alternative to urokinase for treatment of occluded CVADs. However, the practicality of using alteplase as the thrombolytic of choice for this indication remained conjectural. To make this approach economically feasible, alteplase was diluted to 1 mg/mL and 2.5-mL aliquots were stored at -20 degrees C until use. A need to confirm that the cryopreserving and thawing of the reconstituted solution did not compromise the safety and efficacy reported from prior trials was recognized. A quality assessment initiative was undertaken to concurrently monitor the safety and efficacy of this approach. Patients presenting with occluded CVADs received a sufficient volume of the thawed alteplase solution to fill the occluded catheter(s). Data, including efficacy, adverse reactions, dwell time, and catheter type, were collected over a 5-month period.
  
  
  RESULTS
  One hundred twenty-one patients accounting for 168 attempted clearances were assessable for safety and efficacy. One hundred thirty-six (81%) of the 168 catheter clearance attempts resulted in successful catheter clearance (95% confidence interval, 74% to 86%). No adverse events were reported.
  
  
  CONCLUSIONS
  Cryopreserved 1-mg/mL aliquots of alteplase are safe and effective in the clearance of occluded CVADs when stored at -20 degrees C for 30 days. The ability to cryopreserve alteplase aliquots makes it an economically reasonable alternative to urokinase in the setting of CVAD occlusion.
authors.affiliation: Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA. timoneyj@mskcc.org
authors.forename: J P
authors.initials: JP
authors.lastname: Timoney
authors.forename: M G
authors.initials: MG
authors.lastname: Malkin
authors.forename: D M
authors.initials: DM
authors.lastname: Leone
authors.forename: J S
authors.initials: JS
authors.lastname: Groeger
authors.forename: M L
authors.initials: ML
authors.lastname: Heaney
authors.forename: D L
authors.initials: DL
authors.lastname: Keefe
authors.forename: M
authors.initials: M
authors.lastname: Klang
authors.forename: C D
authors.initials: CD
authors.lastname: Lucarelli
authors.forename: R J
authors.initials: RJ
authors.lastname: Muller
authors.forename: S L
authors.initials: SL
authors.lastname: Eng
authors.forename: M
authors.initials: M
authors.lastname: Connor
authors.forename: T N
authors.initials: TN
authors.lastname: Small
authors.forename: A E
authors.initials: AE
authors.lastname: Brown
authors.forename: L B
authors.initials: LB
authors.lastname: Saltz
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002405:Catheterization, Central Venous / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D003362:Cost-Benefit Analysis; D015925:Cryopreservation / Q000592:standards*; D005240:Feasibility Studies; D005260:Female; D005343:Fibrinolytic Agents / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D011786:Quality Control; D010959:Tissue Plasminogen Activator / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D014481:United States; D020246:Venous Thrombosis / Q000188:drug therapy* / Q000209:etiology
chemical_list: D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator