FondaKIDS: A prospective pharmacokinetic and safety study of fondaparinux in children between 1 and 18 years of age

Pediatric Blood and Cancer

Volumn 57, Issue 6, 2011, Pages 1049-1054

  Young, Guy ^a   Yee, Donald L ^b   O'Brien, Sarah H ^c   Khanna, Rachna ^a   Barbour, April ^d   Nugent, Diane J ^e  

^a UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^b BAYLOR COLLEGE OF MEDICINE   (United States)

^c OHIO STATE UNIVERSITY   (United States)

^d GLAXOSMITHKLINE   (United States)

^e CHILDREN S HOSPITAL OF ORANGE COUNTY   (United States)

Author keywords

Anticoagulation; Children; Fondaparinux; Thrombosis

Indexed keywords

FONDAPARINUX;

ADOLESCENT; ADULT; ARTICLE; BRAIN HEMORRHAGE; CHILD; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DEEP VEIN THROMBOSIS; DRESS SYNDROME; DRUG BLOOD LEVEL; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EOSINOPHILIA; FEMALE; GASTROINTESTINAL HEMORRHAGE; HEPARIN INDUCED THROMBOCYTOPENIA; HUMAN; INFANT; MALE; PRESCHOOL CHILD; PRIORITY JOURNAL; SCHOOL CHILD; SIMULATION;

ADOLESCENT; CHILD; CHILD, PRESCHOOL; COHORT STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; DRUG TOXICITY; HEPARIN; HUMANS; INFANT; POLYSACCHARIDES; THROMBOCYTOPENIA; TIME FACTORS; VENOUS THROMBOSIS;

EID: 80052683198     PISSN: 15455009     EISSN: 15455017     Source Type: Journal    
DOI: 10.1002/pbc.23011     Document Type: Article

References (29)

1. Raffini L, Huang YS, Witmer C, Feudtner C. Dramatic increase in venous thromboembolism in children's hospitals in the United States from 2001 to 2007. Pediatrics 2009; 124: 1001-1008.
2. Monagle P, Chalmers E, Chan A, et al. Antithrombotic therapy in neonates and children: american college of chest physicians evidence-based clinical practice guidelines (8th Edition). Chest 2008; 133: 887S-968S.
3. O'Brien SH, Lee H, Ritchey AK. Once-daily enoxaparin in pediatric thromboembolism: a dose finding and pharmacodynamics/pharmacokinetics study. J Thromb Haemost 2007; 5: 1985-1987.
4. Nohe N, Flemmer A, Rumler R, et al. The low molecular weight heparin dalteparin for prophylaxis and therapy of thrombosis in childhood: a report on 48 cases. Eu J Pediatr 1999; 158: S134-S139.
5. Kuhle S, Massicotte P, Dinyari M, et al. Dose-finding and pharmacokinetics of therapeutic doses of tinzaparin in pediatric patients with thromboembolic events. Thromb Haemost 2005; 94: 1164-1171.
6. Zhang Z, Weier M, Li B, et al. Oversulfated chondroitin sulfate: impact of heparin impurity, associated with adverse clinical events, on low molecular weight heparin preparation. J Med Chem 2008; 51: 5498-5501.
7. Rajgopal R, Bear MK, Shaugnessy SG. The effects of heparin and low molecular weight heparin on bone. Thromb Res 2008; 122: 293-298.
8. Shaugnessey SG, Young E, Deschamps P, Hirsh J. The effects of low molecular weight and standard heparin on calcium loss from fetal rat calvaria. Blood 1995; 86: 1368-1373.
9. Samama MM, Gerotziafas GT. Evaluation of the pharmacological properties and clinical results of the synthetic pentasaccharide (fondaparinux). Thromb Res 2003; 109: 1-11.
10. Matziolis G, Perka C, Disch A, Zippel H. Effects of fondaparinux compared with dalteparin, enoxaparin and unfractionated heparin on human osteoblasts. Calcif Tissue Int 2003; 73: 370-379.
11. Lobo B, Finch C, Howard A, Minhas S. Fondaparinux for the treatment of patients with acute heparin-induced thrombocytopenia. Thromb Haemost 2008; 99: 208-214.
12. Young G, Nugent DJ. Use of argatroban and fondaparinux in a child with heparin-induced thrombocytopenia. Pediatr Blood Cancer 2004b; 42: 542.
13. Boshkov LK, Kirby A, Heuschkel M. Pharmacokinetics of fondaparinux by anti-Xa levels and clinical response to anticoagulation in a 4-month old congenital cardiac patient with heparin-induced thrombocytopenia (HIT) and established venous thrombosis transitioned from argatroban to fondaparinux. Blood 2004; 104: 4072 11 Abstract.
14. Grabowski EF, Bussell JB. Pediatric experience with fondaparinux in deep vein thrombosis. Blood 2006; 108: 916 11 Abstract.
15. Mason AR, McBurney PG, Fuller MP, et al. Successful use of fondaparinux as an alternative anticoagulatnt in a 2-month-old infant. Pediatr Blood Cancer 2008; 50: 1084-1085.
16. Maurer SH, Wiliams JA, Wang WC, Reiss UM. Heparin induced thrombocytopenia and re-thrombosis associated with warfarin and fondaparinux in a child. Pediatr Blood Cancer 2009; 53: 468-471.
17. Caviness VS, Jr., Sagar P, Israel EJ, et al. Case 38-2006: A 5-year-old boy with headache and abdominal pain. N Eng J Med 2006; 355: 2575-2584.
18. Sharathkumar AA, Crandall C, Lin JJ, Pipe S. Treatment of thrombosis with fondaparinux (Arixtra) in a patient with end-stage renal disease receiving hemodialysis therapy. J Pediatr Hematol Oncol 2007; 29: 581-584.
19. (accessed November 8, 2010).
20. Donat F, Durel JP, Santoni A, et al. The pharmacokinetics of fondaparinux sodium in healthy volunteers. Clin Pharmacokinet 2002; 41: 1-9.
21. Arixtra (fondaparinux sodium) prescribing Information, (accessed September 26, 2010).
22. Nowak-Gottl U, Bindlignmaier C, Krumpel A, Gottl L, Kenet G. Pharmacokinetic, safety, and efficacy of LMWHs in venous thrombosis and stroke in neonates, infants, and children. Br J Pharmacol 2008; 153: 1120-1127.
23. Trame MN, Mitchell L, Krumpel A, et al. Population pharmacokinetics of enoxaparin in infants, children, and adolescents during secondary thromboembolic prophylaxis: a cohort study. J Thromb Haemost 2010; 8: 195-198.
24. Chong BH, Chong JJ. Heparin-induced thrombocytopenia associated with fondaparinux. Clin Adv Hematol Oncol 2010; 8: 63-65.
25. Sutor AH, Chan AK, Massicotte P. Low-molecular-weight heparin in pediatric patients. Semin Thromb Hemost 2004; 30: 31-39.
26. Kishimoto TK, Viswanathan K, Ganguly T, et al. Contaminated heparin associated with adverse clinical events and activation of the contact system. N Eng J Med 2008; 358: 2457-2467.
27. Lassen MR, Bauer KA, Eriksson BI, Turpie AG. Postoperative fondaparinux versus preoperative enoxaparin for prevention of venous thromboembolism in elective hip-replacement surgery: a randomized double-blind comparison. Lancet 2002; 359: 1715-1720.
28. Massicotte P, Adams M, Marzinotto V, et al. Low-molecular-weight heparin in pediatric patients with thrombotic disease: a dose finding study. J Pediatr 1996; 128: 313-318.
29. Punzalan RC, Hillery CA, Montgomery RR, et al. Low-molecular-weight heparin in thrombotic disease in children and adolescents. J Pediatr Hematol Oncol 2000; 22: 137-142.