Consensus protocol for the use of recombinant activated factor VII [eptacog alfa (activated); NovoSeven®] in elective orthopaedic surgery in haemophilic patients with inhibitors

• Published in: Haemophilia : the official journal of the World Federation of Hemophilia Vol. 15; no. 2; pp. 501 - 508
• Main Authors: GIANGRANDE, P. L. F., WILDE, J. T., MADAN, B., LUDLAM, C. A., TUDDENHAM, E. G. D., GODDARD, N. J., DOLAN, G., INGERSLEV, J.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01-03-2009
• Subjects: Adolescent; Adult; Aged; Blood Loss, Surgical - prevention & control; Child; Child, Preschool; Clinical Protocols; Consensus Development Conferences as Topic; Elective Surgical Procedures; Factor VIIa - therapeutic use; haemophilia; Hemophilia A - complications; Hemophilia A - drug therapy; Humans; inhibitors; Joint Diseases - surgery; Middle Aged; NovoSeven; orthopaedic surgery; Orthopedic Procedures - adverse effects; Postoperative Hemorrhage - prevention & control; protocol; recombinant activated factor VII; Recombinant Proteins - therapeutic use; Treatment Outcome; Young Adult
• ISSN: 1351-8216; 1365-2516
• DOI: 10.1111/j.1365-2516.2008.01952.x

Patients with haemophilia complicated by inhibitors have a significant burden of joint disease, which is associated with a negative impact on their quality of life. Successful elective orthopaedic surgery can result in decreased bleed frequency into a new joint, less time spent in hospital, increased mobility and improved well being. This paper describes a new protocol for use of recombinant activated factor VII (rFVIIa) in elective orthopaedic surgery, based on a review of published data as well as the personal experience of a group of expert physicians. The protocol offers guidance on the planning of the surgery and preoperative testing as well as the bolus schedule for rFVIIa and advice on the concomitant use of antifibrinolytic agents and fibrin sealants. A total of 10 operations involving 13 procedures in eight patients in five comprehensive care centres have been undertaken until now using the protocol, which employs an initial bolus dose of rFVIIa in the range of 120–180 μg kg−1 to cover surgery. The clinical experience reported here encompasses all cases of elective orthopaedic surgery using rFVIIa as initial treatment carried out in the UK and Republic of Ireland over the last 2 years. In all cases, there was good control of haemostasis during surgery and the final outcome was rated as ‘excellent’ or ‘extremely satisfactory’ by the reporting clinicians. Although the initial cost of product to cover surgery such as arthroplasty is high, it needs to be borne in mind that this may be offset in subsequent years by savings resulting from avoidance of bleeding episodes in the affected joint.