Clinical efficacy and safety of the factor VIII/von Willebrand factor concentrate BIOSTATE® in patients with von Willebrand's disease: A prospective multi-centre study

Haemophilia

Volumn 16, Issue 4, 2010, Pages 615-624

  Dunkley, S ^a   Baker, R I ^b   Pidcock, M ^c   Price, J ^d   Seldon, M ^e   Smith, M ^f   Street, A ^g   Maher, D ^h   Barrese, G ^h   Stone, C ^h   Lloyd, J ⁱ  

^a ROYAL PRINCE ALFRED HOSPITAL   (Australia)

^b MURDOCH UNIVERSITY   (Australia)

^c CANBERRA HOSPITAL   (Australia)

^d PRINCESS MARGARET HOSPITAL FOR CHILDREN   (Australia)

^e NEWCASTLE MATER HOSPITAL   (Australia)

^f CHRISTCHURCH HOSPITAL   (New Zealand)

^g ALFRED HOSPITAL   (Australia)

^h CSL LIMITED   (Australia)

ⁱ ROYAL ADELAIDE HOSPITAL   (Australia)

Author keywords

BIOSTATE; Bleeding; Prophylaxis; Surgery; Von Willebrand disease; Von Willebrand factor

Indexed keywords

BIOSTATE; BLOOD CLOTTING FACTOR 8 CONCENTRATE; DESMOPRESSIN; UNCLASSIFIED DRUG;

ADULT; AGED; ARTICLE; BLOOD TRANSFUSION; CLINICAL ARTICLE; CLINICAL TRIAL; DEEP VEIN THROMBOSIS; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG SAFETY; DYSPNEA; FEMALE; HEMOSTASIS; HUMAN; LIVER FUNCTION TEST; LUNG EMBOLISM; MALE; MULTICENTER STUDY; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROPHYLAXIS; PROSPECTIVE STUDY; SIDE EFFECT; THROMBOPHLEBITIS; VON WILLEBRAND DISEASE;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; CHILD; CHILD, PRESCHOOL; DRUG ADMINISTRATION SCHEDULE; DRUG COMBINATIONS; FACTOR VIII; FEMALE; HEMORRHAGE; HEMOSTASIS; HUMANS; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; VIRUS INACTIVATION; VON WILLEBRAND DISEASES; VON WILLEBRAND FACTOR; YOUNG ADULT;

EID: 77954858671     PISSN: 13518216     EISSN: 13652516     Source Type: Journal    
DOI: 10.1111/j.1365-2516.2010.02206.x     Document Type: Article

References (29)

1. Sadler JE, Budde U, Eikenboom JCJ. Update on the pathophysiology and classification of von Willebrand disease: a report of the Subcommittee on von Willebrand Factor. J Thromb Haemost 2006, 4:2103-14.
2. Nichols WL, Hultin MB, James AH. von Willebrand disease (VWD): evidence-based diagnosis and management guidelines, the National Heart, Lung and Blood Instiute (NHLBI) expert panel report (USA). Haemophilia 2008, 14:171-232.
3. Federici AB, Mannucci PM. Management of inherited von Willebrand disease in 2007. Ann Med 2007, 39:346-58.
4. Michiels JJ, Gadisseur A, Budde U. Characterization, classification, and treatment of von Willebrand Diseases: a critical appraisal of the literature and personal experiences. Semin Thromb Hemost 2005, 31:577-601.
5. Mannucci PM. Treatment of von Willebrand's disease. N Eng J Med 2004, 351:683-94.
6. Lubetsky A, Schulman S, Varcn D. Safety and efficacy of continuous infusion of a combined factor VIII-von Willebrand factor (vWF) concentrate (Haemate-P) in patients with von Willebrand disease. Thromb Haemost 1999, 81:229-33.
7. Mannucci PM, Chediak J, Hanna W. Treatment of von Willebrand disease with a high-purity factor VIII/von Willebrand factor concentrate: a prospective, multicenter study. Blood 2002, 99:450-6.
8. Cox Gill J, Ewenstein BM, Thompson AR, Mueller-Veltens G, Schwartz BA. Successful treatment of urgent bleeding in von Willebrand disease with factor VIII/VWF concentrate (Humate-P): use of the ristocetin cofactor assay (VWF:RCo) to measure potency and to guide therapy. Haemophilia 2003, 9:688-95.
9. Michiels JJ, Berneman ZN, van der Planken M, Schroyens W, Budde U, van Vliet HHDM. Bleeding prophylaxis for major surgery in patients with type 2 von Willebrand disease with an intermediate purity factor VIII-von Willebrand factor concentrate (Haemate-P). Blood Coagul Fibrinolysis 2004, 15:323-30.
10. Thompson AR, Gill JC, Ewenstein BM, Mueller-Velten G, Schwartz BA. Successful treatment for patients with von Willebrand disease undergoing urgent surgery using factor VIII/VWF concentrate (Humate-P®). Haemophilia 2004, 10:42-51.
11. Borel-Derlon A, Federici AB, Roussel-Robert V. Treatment of severe von Willebrand disease with a high-purity von Willebrand factor concentrate (Wilfactin®): a prospective study of 50 patients. J Thromb Haemost 2007, 5:1115-24.
12. Lethagen S, Kyrle PA, Castaman G, Haertel S, Mannucci PM. Von Willebrand factor/factor VIII concentrate (Haemate® P) dosing based on pharmacokinetics: a prospective multicenter trial in elective surgery. J Thromb Haemost 2007, 5:1420-30.
13. Bello IF, Yuste VJ, Molina MQ, Navarro FH. Fanhdi®, efficacy and safety in von Willebrand's disease: prospective international study results. Haemophilia 2007, 13(Suppl. 5):25-32.
14. Favaloro EJ, Bukuya M, Martinelli T. A comparative multi-laboratory assessment of three factor VIII/von Willebrand factor concentrates. Thromb Haemost 2002, 87:466-76.
15. Favaloro EJ, Lloyd J, Rowell J. Comparison of the pharmacokinetics of two von Willebrand factor concentrates [Biostate and AHF (High Purity)] in people with von Willebrand disorder. Thromb Haemost 2007, 97:922-30.
16. Shortt J, Dunkley S, Rickard K, Baker R, Street A. Efficacy and safety of a high purity, double virus inactivated factor VIII/von Willebrand factor concentrate (Biostate®) in patients with von Willebrand disorder requiring invasive or surgical procedures. Haemophilia 2007, 13:144-8.
17. Budde U, Metzner HJ, Muller HG. Comparative analysis and classification of von Willebrand factor/factor VIII concentrates: impact on treatment of patients with von Willebrand disease. Semin Thromb Hemost 2006, 32:626-35.
18. Mazurier C. Composition, quality control, and labeling of plasma-derived products for the treatment of von Willebrand disease. Semin Thromb Hemost 2006, 32:529-36.
19. Metzner HJ, Hermentin P, Cuesta-Linker T, Langner S, Muller H-G, Friedebold J. Characterization of factor VIII/von Willebrand factor concentrates using a modified method of von Willebrand factor multimer analysis. Haemophilia 1998, 4(Suppl. 3):25-32.
20. Reininger AJ. Function of von Willebrand factor in haemostasis and thrombosis. Haemophilia 2008, 14(Suppl. 5):11-26.
21. Australian Haemophilia Centre Directors' Organisation. Submission to the Department of Health and Ageing Review of Australia's Plasma Fractionation Arrangements. 2005, http://www.ahcdo.org.au/publications/cid/2/parent/0/t/publications/parent_name/GeneralPublications, Available at. Accessed December 15, 2008
22. Federici AB, Baudo F, Caracciolo C. Clinical efficacy of highly purified, doubly virus-inactivated factor VIII/von Willebrand factor concentrate (Fanhdi®) in the treatment of von Willebrand disease: a retrospective clinical study. Haemophilia 2002, 8:761-7.
23. Franchini M, Rossetti G, Tagliaferri A. Efficacy and safety of factor VIII/von Willebrand's factor concentrate (Haemate-P®) in preventing bleeding during surgery or invasive procedures in patients with von Willebrand disease. Haematologica 2003, 88:1279-83.
24. Federici AB, Castaman G, Franchini M. Clinical use of Haemate-P in inherited von Willebrand's disease: a cohort study on 100 Italian patients. Haematologica 2007, 92:944-51.
25. Pasi KJ, Collins PW, Keeling DM. Management of von Willebrand disease: a guideline from the UK Haemophilia Centre Doctor's Organization. Haemophilia 2004, 10:218-31.
26. van Vliet HHDM, Kappers-Klunne MC, Leebeek FWG, Michiels JJ. PFA-100 monitoring of von Willebrand factor (VWF) responses to desmopressin (DDAVP) and factor VIII/VWF concentrate substitution in von Willebrand disease type 1 and 2. Thromb Haemost 2008, 100:462-8.
27. Makris M, Colvin B, Gupta V, Shields ML, Smith MP. Venous thrombosis following the use of intermediate purity FVIII concentrate to treat patients with von Willebrand's disease. Thromb Haemost 2002, 88:387-8.
28. Mannucci PM. Venous thromboembolism in von Willebrand disease. Thromb Haemost 2002, 88:378-9.
29. Martinelli I. von Willebrand factor and factor VIII as risk factors for arterial and venous thrombosis. Semin Hematol 2005, 42:49-55.