Safe and cost effective use of alteplase for the clearance of occluded central venous access devices Journal Article

Authors: Timoney, J. P.; Malkin, M. G.; Leone, D. M.; Groeger, J. S.; Heaney, M. L.; Keefe, D. L.; Klang, M.; Lucarelli, C. D.; Muller, R. J.; Eng, S. L.; Connor, M.; Small, T. N.; Brown, A. E.; Saltz, L. B.
Article Title: Safe and cost effective use of alteplase for the clearance of occluded central venous access devices
Abstract: Purpose: 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). Materials and 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°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. Conclusion: Cryopreserved 1-mg/mL aliquots of alteplase are safe and effective in the clearance of occluded CVADs when stored at -20°C for 30 days. The ability to cryopreserve alteplase aliquots makes it an economically reasonable alternative to urokinase in the setting of CVAD occlusion. © 2002 by American Society of Clinical Oncology.
Keywords: adolescent; adult; child; controlled study; aged; child, preschool; middle aged; major clinical study; drug efficacy; drug safety; united states; cancer patient; quality control; cost effectiveness analysis; cryopreservation; thawing; infant; feasibility studies; thrombosis; cost-benefit analysis; drug stability; drug induced disease; tissue plasminogen activator; fibrinolytic agent; fibrinolytic agents; alteplase; urokinase; central venous catheter; reaction time; drug choice; catheterization, central venous; venous thrombosis; blood clot lysis; vascular access; humans; human; male; female; priority journal; article
Journal Title: Journal of Clinical Oncology
Volume: 20
Issue: 7
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2002-04-01
Start Page: 1918
End Page: 1922
Language: English
DOI: 10.1200/jco.2002.07.131
PUBMED: 11919252
PROVIDER: scopus
Notes: Export Date: 14 November 2014 -- Source: Scopus
Altmetric Score
MSK Authors
  1. Stella Lee Eng
    6 Eng
  2. Trudy Small
    200 Small
  3. Leonard B Saltz
    599 Saltz
  4. Mark L Heaney
    90 Heaney
  5. Diane Leone
    3 Leone
  6. Deborah Keefe
    28 Keefe
  7. Mark Malkin
    26 Malkin
  8. Jeffrey Groeger
    52 Groeger
  9. Arthur E Brown
    45 Brown
  10. Mary Ann Connor
    5 Connor
  11. Mark G Klang
    19 Klang
  12. Raymond J Muller
    14 Muller
  13. John Patrick Timoney
    10 Timoney