Trend to efficacy and safety using antithrombin concentrate in prevention of thrombosis in children receiving l-asparaginase for acute lymphoblastic leukemia: Results of the PARKAA study

Thrombosis and Haemostasis

Volumn 90, Issue 2, 2003, Pages 235-244

  Mitchell, Lesley ^a   Andrew, Maureen ^a   Hanna, Kim ^b   Abshire, Thomas ^c   Halton, Jacqueline ^d   Wu, John ^e   Anderson, Ron ^f   Cherrick, Irene ^g   Desai, Sunil ^h   Mahoney, Donald ⁱ   McCusker, Patricia ^a   Chait, Peter ^a   Abdolell, Mohamed ^a   De Veber, Gabrielle ^a   Mikulis, David ^j  

^a HOSPITAL FOR SICK CHILDREN   (Canada)

^b Bayer Inc   (Canada)

^c EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d CHILDREN S HOSPITAL OF EASTERN ONTARIO   (Canada)

^e BC CHILDREN S HOSPITAL   (Canada)

^f ALBERTA CHILDREN'S HOSPITAL   (Canada)

^g University Hospital   (United States)

^h UNIVERSITY OF ALBERTA   (Canada)

ⁱ BAYLOR COLLEGE OF MEDICINE   (United States)

^j TORONTO GENERAL HOSPITAL   (Canada)

more..

Author keywords

Acute lymphoblastic leukemia; Antithrombin concentrate; L asparaginase; Paediatric; Thrombosis

Indexed keywords

ACTIVATED PROTEIN C; ALPHA 1 ANTITRYPSIN; ANTITHROMBIN III CONCENTRATE; ASPARAGINASE; BLOOD CLOTTING FACTOR 5 LEIDEN; CYTARABINE; DAUNORUBICIN; HEPARIN; MARKER; METHOTREXATE; PREDNISONE; PROTHROMBIN; PROTHROMBIN FRAGMENT 1.2; THROMBATE III; THROMBIN; THROMBIN ANTITHROMBIN COMPLEX; UNCLASSIFIED DRUG; VINCRISTINE;

ACUTE LYMPHOBLASTIC LEUKEMIA; ADOLESCENT; ARTICLE; BLEEDING; CANCER CHEMOTHERAPY; CENTRAL VENOUS CATHETERIZATION; CHILD; CHILD HEALTH CARE; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE MARKER; DOPPLER ECHOGRAPHY; DRUG EFFICACY; DRUG INFUSION; DRUG SAFETY; FEMALE; HUMAN; INCIDENCE; MAJOR CLINICAL STUDY; MALE; NUCLEAR MAGNETIC RESONANCE IMAGING; OPEN STUDY; PHASE 2 CLINICAL TRIAL; PHLEBOGRAPHY; POPULATION RESEARCH; PRIORITY JOURNAL; PROPHYLAXIS; RANDOMIZED CONTROLLED TRIAL; THROMBOEMBOLISM; THROMBOSIS; TREATMENT OUTCOME;

EID: 12444304442     PISSN: 03406245     EISSN: None     Source Type: Journal    
DOI: 10.1160/th02-11-0283     Document Type: Article

References (44)

1. Bjork I, Danielsson A, Fenton JW, et al. The site in human antithrombin for functional proteolytic cleavage by human thrombin. FEBS Lett 1981; 126: 257-60.
2. Lane DA, Caso R. Antithrombin: Structure, genomic organization, function and inherited deficiency. Baillieres Clin Haematol 1989; 2: 961-98.
3. Hirsh J. Approach to Patients with Inherited Thrombophilia. Hamilton, B.C. Decker Inc., 1998.
4. Andrew M, David M, Adams M, et al. Venous thromboembolic complications (VTE) in children: First analyses of the Canadian Registry of VTE. Blood 1994; 83: 1251-7.
5. Van Ommen CH, Heijboer H, Buller HR, et al. Venous thromboembolism in childhood: A prospective two-year registry in The Netherlands. J Pediatr 2001; 139: 676-81.
6. Andrew M, Brooker LA. Blood component therapy in neonatal hemostatic disorders. Transfus. Med Rev 1995; 9: 231-50.
7. Tait RC, Walker ID, Perry DJ, et al. Prevalence of antithrombin deficiency in the healthy population. Br J Haematol 1994; 87: 106-12.
8. Heijboer H, Brandjes DP, Buller HR, et al. Deficiencies of coagulation-inhibiting and fibrinolytic proteins in outpatients with deep-vein thrombosis. N Engl J Med 1990; 323: 1512-6.
9. Bauer K. Rare hereditary coagulation factor abnormalities, in Nathan DG, Oski FA (eds): Hematology of Infancy and Childhood. Philadelphia, W.B. Saunders, 1998; 1660-75.
10. Pui CH, Evans WE. Acute lymphoblastic leukemia. N Engl J Med 1998; 339: 605-15.
11. Haley E, Fischer G, Welch A. The requirement for L-asparaginase of mouse leukemic cell L-5178y in culture. Cancer Res 1961; 21: 532-3.
12. Mitchell LG, Halton JM, Vegh PA, et al. Effect of disease and chemotherapy on hemostasis in children with acute lymphoid leukemia. Am J Pediatr Hematol. Oncol 1994; 16: 120-6.
13. Sutor A, Ritter J. Thrombosis in children with acute lymphoblastic leukemia with special regard to asparaginase treatment. Hemostaseologie 1992; 12: 35-43.
14. Pui CH, Jackson CW, Chesney CM, et al. Involvement of von Willebrand factor in thrombosis following asparaginase-prednisone-vincristine therapy for leukemia. Am J Hematol 1987; 25: 291-8.
15. Ott N, Ramsay NK, Priest JR, et al. Sequelae of thrombotic or hemorrhagic complications following L- asparaginase therapy for childhood lymphoblastic leukemia. Am J Pediatr Hematol Oncol 1988; 10: 191-5.
16. Pui CH, Chesney CM, Bergum PW, et al. Lack of pathogenetic role of proteins C and S in thrombosis associated with asparaginase-prednisone-vincristine therapy for leukaemia. Br J Haematol 1986; 64: 283-90.
17. Priest J, Ramsay K, Steinherz P, et al. A syndrome of thrombosis and hemorrhage complicating L-asparaginase therapy for childhood acute lymphoblastic leukemia. J Pediatr 1982; 100: 984-9.
18. Mitchell L, Hoogendoorn H, Giles AR, et al. Increased endogenous thrombin generation in children with acute lymphoblastic leukemia: Risk of thrombotic complications in L'Asparaginase-induced antithrombin III deficiency. Blood 1994; 83: 386-91.
19. Mitchell L, Sutor A, Andrew M. Hemostasis in childhood acute lymphoblastic leukemia: Coagulopathy induced by disease and treatment. Semin Thromb Hemost 1995; 21(4): 390-401.
20. Nowak-Gottl U, Aschka I, Koch HG, et al. Resistance to activated protein C (APCR) in children with acute lymphoblastic leukaemia - The need for a prospective multicentre study. Blood Coagul Fibrinolysis 1995; 6: 761-4.
21. Nowak-Gottl U, Wermes C, Junker R, et al. Prospective evaluation of the thrombotic risk in children with acute lymphoblastic leukemia carrying the MTHFR TT 677 genotype, the prothrombin G20210A variant, and further prothrombotic risk factors. Blood 1999; 93: 1595-9.
22. Mauz-Korholz C, Junker R, Gobel U, et al. Prothrombotic risk factors in children with acute lymphoblastic leukemia treated with delayed E. coli asparaginase (COALL-92 and 97 protocols). Thromb Haemost 2000; 83: 840-3.
23. Pastore G, Miniero R, Saracco P, et al. Thrombosis and hemorrhage during L-asparaginase therapy. J Pediatr 1983; 102: 639-40.
24. Kucuk O, Kwaan HC, Gunnar W, et al. Thromboembolic complications associated with L-asparaginase therapy. Etiologic role of low antithrombin III and plasminogen levels and therapeutic correction by fresh frozen plasma. Cancer 1985; 55: 702-6.
25. Mitchell LG, the PAARKA Investigators. A prospective cohort study determining the prevalence of thrombotic events in children with acute lymphoblastic leukemia and a central venous line who are treated with L-asparaginase. Cancer 2003; 97: 508-16.
26. Abshire TC, Gold SH, Odom LF, et al. The coagulopathy of childhood leukemia. Thrombin activation or primary fibrinolysis? Cancer 1990; 66: 716-21
27. Gugliotta L, D'Angelo A, Mattioli BM, et al. Hypercoagulability during L-asparaginase treatment: The effect of antithrombin III supplementation in vivo. Br J Haematol 1990; 74: 465-70.
28. Semeraro N, Montemurro P, Giordano P, et al. Unbalanced coagulation-fibrinolysis potential during L-asparaginase therapy in children with acute lymphoblastic leukaemia. Throm Haemost 1990; 64: 38-40.
29. Nowak-Gottl U, Wolff J, Kuhn N, et al. Enhanced thrombin generation, P-von Willebrand factor, P-fibrin D-dimer and P-plasminogen activation inhibitor-1: Predictive for venous thrombosis in asparaginase treated children. Fibrinolysis 1994; 8: 63-5.
30. Sutor AH, Niemeyer C, Sauter S, et al. Changes in blood coagulation in treatment with ALL-BFM-90 and NHL-BFM- 90 protocols. Klin Padiatr 1992; 204: 264-73.
31. Nowak-Gottl U, Ahlke E, Klosel K, et al. Changes in coagulation and fibrinolysis in childhood acute lymphoblastic leukaemia re-induction therapy using three different asparaginase preparations. Eur J Pediatr 1997; 156: 848-50.
32. Halton JM, Mitchell LG, Vegh P, et al. Fresh frozen plasma has no beneficial effect on the hemostatic system in children receiving L-asparaginase. Am J Hematol 1994; 47: 157-61.
33. Nowak-Gottl U, Rath B, Binder M, et al. Inefficacy of fresh frozen plasma in the treatment of L-asparaginase- induced coagulation factor deficiencies during ALL induction therapy. Haematologica 1995; 80: 451-3.
34. Bauer KA, Teitel JM, Rosenberg RD. L-asparaginase induced antithrombin III deficiency: Evidence against the production of a hypercoagulable state. Thromb Res 1983; 29: 437-42.
35. Nowak-Gottl U, Kuhn N, Wolff JEA, et al. Inhibition of hypercoagulation by antithrombin substitution in E coli L-asparaginase treated children. Eur J Haematol 1996; 56: 35-8.
36. Pogliani EM, Parma M, Baragetti I, et al. L-asparaginase in acute lymphoblastic leukaemia treatment: The role of human antithrombin III concentrates in regulating the prothrombotic state induced by therapy. Acta Haematol 1995; 93: 5-8.
37. Mazzucconi MG, Gugliotta L, Leone G, et al. Antithrombin III infusion suppresses the hypercoagulable state in adult acute lymphoblastic leukaemia patients treated with a low dose of Escherichia coli L-asparaginase. A GIMEMA study. Blood Coagul Fibrinolysis 1994; 5: 23-8.
38. Cohn E, Strong L, Hughes W., Jr., et al.: Preparation and properties of serum and plasma proteins. IV. A system for the separation into fractions of the protein and lipoprotein components of biological tissues and fluids. J Am Chem Soc 1946; 68: 459-65.
39. Espana F, Gruber A, Heeb MJ, et al. In vivo and in vitro complexes of activated protein C with two inhibitors in baboons. Blood 1991; 77: 1754-60.
40. Ardissino D, Merlini PA, Eisenberg PR, et al. Coagulation markers and outcomes in acute coronary syndromes. Am Heart J 1998; 136: S7-18.
41. Brandt JT, Triplett DA, Alving B, et al. Criteria for the diagnosis of lupus anticoagulants: An update. On behalf of the Subcommittee on Lupus Anticoagulant/Antiphospholipid Antibody of the Scientific and Standardisation Committee of the ISTH. Thromb Haemost 1995; 74: 1185-90.
42. Perry DJ, Pasi KJ. Resistance to activated protein C and factor V Leiden. QJM. 1997; 90: 379-85.
43. Poort SR, Rosendaal FR, Reitsma PH, et al. A common genetic variation in the 3′-untranslated region of the prothrombin gene is associaetd with elevated plasma prothrombin levels and an increase in venous thrombosis. Blood 1996; 88: 3698-703.
44. Schmidt B, Gillie P, Mitchell L, et al. A placebo-controlled randomized trial of antithrombin therapy in neonatal respiratory distress syndrome. Am J Respir Crit Care Med 1998; 158: 470-6.