Safety and efficacy of turoctocog alfa (NovoEight®) during surgery in patients with haemophilia A: Results from the multinational guardian™ clinical trials

Haemophilia

Volumn 21, Issue 1, 2015, Pages 34-40

  Santagostino, E ^a   Lentz, S R ^b   Misgav, M ^c   Brand, B ^d   Chowdary, P ^e   Savic, A ^f   Kilinc, Y ^g   Amit, Y ^h   Amendola, A ^b   Solimeno, L P ⁱ   Saugstrup, T ^j   Matytsina, I ^j  

^a FONDAZIONE IRCCS CA GRANDA OSPEDALE MAGGIORE POLICLINICO   (Italy)

^b UNIVERSITY OF IOWA   (United States)

^c SHEBA MEDICAL CENTER   (Israel)

^d UNIVERSITY HOSPITAL ZURICH   (Switzerland)

^e ROYAL FREE HOSPITAL   (United Kingdom)

^f UNIVERSITY OF NOVI SAD   (Serbia)

^g CUKUROVA UNIVERSITY   (Turkey)

^h Tel Hashomer Hosp   (Israel)

ⁱ CTO Hospital   (Italy)

^j NOVO NORDISK A S   (Denmark)

more..

Author keywords

Clinical trial; Haemophilia A; NovoEight ; Recombinant factor VIII; Surgery; Turoctocog alfa

Indexed keywords

ANTIFIBRINOLYTIC AGENT; RECOMBINANT BLOOD CLOTTING FACTOR 8; TRANEXAMIC ACID; BLOOD CLOTTING FACTOR 8; RECOMBINANT FACTOR VIII N8;

ABDOMINAL SURGERY; ADOLESCENT; ADULT; ARTICLE; BLEEDING; CHILD; CLINICAL ARTICLE; CONTINUOUS INFUSION; DENTAL PROCEDURE; DISEASE SEVERITY; DRUG EFFICACY; DRUG EXPOSURE; DRUG RESPONSE; DRUG SAFETY; FEMALE; HEMOPHILIA A; HEMOSTASIS; HUMAN; JOINT PROSTHESIS; LOADING DRUG DOSE; MAJOR SURGERY; MALE; MINIMUM PLASMA CONCENTRATION; MINOR SURGERY; OPEN STUDY; ORTHOPEDIC SURGERY; PRIORITY JOURNAL; THROMBOSIS PREVENTION; TREATMENT OUTCOME; YOUNG ADULT; MIDDLE AGED; PRESCHOOL CHILD;

ADOLESCENT; ADULT; CHILD; CHILD, PRESCHOOL; FACTOR VIII; FEMALE; HEMOPHILIA A; HUMANS; MALE; MIDDLE AGED; YOUNG ADULT;

EID: 84921509343     PISSN: 13518216     EISSN: 13652516     Source Type: Journal    
DOI: 10.1111/hae.12518     Document Type: Article

References (14)

1. Luck JV Jr, Kasper CK. Surgical management of advanced hemophilic arthropathy. An overview of 20 years' experience. Clin Orthop Relat Res 1989; 242: 60-82.
2. Chevalier Y, Dargaud Y, Lienhart A, Chamouard V, Negrier C. Seventy-two total knee arthroplasties performed in patients with haemophilia using continuous infusion. Vox Sang 2013; 104: 135-43.
3. Ingerslev J, Hvid I. Surgery in hemophilia. The general view: patient selection, timing, and preoperative assessment. Semin Hematol 2006; 43(1 Suppl 1): S23-6.
4. Thim L, Vandahl B, Karlsson J et al. Purification and characterization of a new recombinant factor VIII (N8). Haemophilia 2010; 16: 349-59.
5. Christiansen ML, Balling KW, Persson E et al. Functional characteristics of N8, a new recombinant FVIII. Haemophilia 2010; 16: 878-87.
6. TM1) using prophylactic treatment with turoctocog alfa in adolescent and adult patients with severe haemophilia A: safety and efficacy. Haemophilia 2013; 19: 691-7.
7. TM3) using prophylactic treatment with turoctocog alfa in paediatric patients with severe haemophilia A: safety, efficacy and pharmacokinetics. Haemophilia 2013; 19: 698-705.
8. WMA. Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. 2010.
9. ICH.Tripartite harmonised guideline: Good Clinical Practice: Consolidated Guideline (E6). 2010.
10. Brewer A, Correa ME. Guidelines for dental treatment of patients with inherited bleeding disorders. Treatment of Hemophilia Monograph. Montreal, Canada: World Federation of Hemophilia, 2006.
11. Negrier C, Shapiro A, Berntorp E et al. Surgical evaluation of a recombinant factor VIII prepared using a plasma/albumin-free method: efficacy and safety of Advate in previously treated patients. Thromb Haemost 2008; 100: 217-23.
12. Martinowitz U, Luboshitz J, Bashari D et al. Stability, efficacy, and safety of continuously infused sucrose-formulated recombinant factor VIII (rFVIII-FS) during surgery in patients with severe haemophilia. Haemophilia 2009; 15: 676-85.
13. Windyga J, Rusen L, Gruppo R et al. BDDrFVIII (Moroctocog alfa [AF-CC]) for surgical haemostasis in patients with haemophilia A: results of a pivotal study. Haemophilia 2010; 16: 731-9.
14. Amby LK, Seremetis S, Obergfell A, Bjerre J. Challenges of defining reliable clinical surrogate end points in haemophilia trials: a critical review. Blood Coagul Fibrinolysis 2009; 20: 488-93.