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PEDIATRICS

Anti-Xa Stability of Diluted Dalteparin for Pediatric Use

Assistant Professor of Pediatrics and Medicine (Hematology); Associate Director, Mountain States Regional Hemophilia and Thrombosis Center and Coagulation Research Laboratory, University of Colorado and The Children's Hospital, Aurora, CO

Linda Jacobson, MT

Laboratory Supervisor and Senior Technologist, Mountain States Regional Hemophilia and Thrombosis Center and Coagulation Research Laboratory, University of Colorado

Hannah Hathaway

Laboratory Technology Student, Mountain States Regional Hemophilia and Thrombosis Center and Coagulation Research Laboratory, University of Colorado

Mark Tripputi, MS

Biostatistician and Research Instructor, Department of Preventive Medicine and Biometrics, University of Colorado at Denver Health Sciences Center

Judy Primeaux, BSPharm MA

Clinical and Research Pharmacist and Pharmacy Director, Mountain States Regional Hemophilia and Thrombosis Center, University of Colorado

Jason Child, PharmD

Clinical and Investigational Pharmacist, The Children's Hospital, Aurora

Reprints: Dr. Goldenberg, Mountain States Regional Hemophilia and Thrombosis Center and Coagulation Research Laboratory, PO Box 6507, Aurora, CO 80045, neil.goldenberg{at}uchsc.edu

BACKGROUND: The low-molecular-weight heparin (LMWH) dalteparin is approved by the Food and Drug Administration for prophylaxis of venous thromboembolism (VTE) in adults and has recently received an indication for acute VTE therapy in adults with cancer. Published reports of experience with dalteparin use in European children suggest that this LMWH agent is safe and effective in the prophylaxis and treatment of VTE in the pediatric population. However, dalteparin is commonly available in the US in a concentrated form that requires dilution for accurate administration in infants and young children.

OBJECTIVE: To investigate the in vitro stability of diluted dalteparin for pediatric use, as measured by serial anti-Xa activity assays over the course of 4 weeks.

METHODS: At 2 clinical research pharmacies, dalteparin multidose vials (anti-Xa concentration 25,000 U/mL) of the 2 distinct lots presently available for clinical use were diluted 1:10 with preservative-free NaCl 0.9% and maintained in tuberculin syringes at 4 °C. Syringes were then sampled for anti-Xa activity by chromogenic assay at baseline and weekly over the course of 4 weeks.

RESULTS: For each lot of dalteparin, there was strong agreement in anti-Xa activity between corresponding diluted syringes prepared at the 2 pharmacy sites. No statistically significant difference in anti-Xa activity was detected from baseline to any time point, nor was a trend of change detected in anti-Xa activity with time for either lot of dalteparin.

CONCLUSIONS: These data indicate that the anti-Xa activity of diluted dalteparin for pediatric use is stable over the course of 4 weeks.

Key Words: anti-Xa, dalteparin, low-molecular-weight heparin, pediatrics, thrombosis

Published Online, March 18, 2008. www.theannals.com, DOI 10.1345/aph.1K609