In the haemophilic patient, development of antibodies that inhibit the
function of the missing coagulation factor causes several delicate pr
oblems. Most importantly, antibodies will block the function of the sp
ecific coagulation factor, and often the antibody activity is so fierc
e that effective substitution therapy is outruled. In consequence, alt
ernative measures must be adopted to control bleeding. Amongst those m
ost commonly employed, like factor IX concentrates? activated prothrom
bin complex concentrates, and factor VIII of porcine origin, a new rec
ombinant activated factor VII molecule has been evaluated clinically f
or some years with promising results. The aim of the present paper was
to present a series of patients suffering from haemophilia A or B in
whom inhibitors have complicated the clinical picture, and in whom a s
urgical procedure was indicated. As part of a compassionate use progra
m devised by the producer of this genetically engineered factor VIIa,
12 patients underwent life-saving or essential surgery where the recom
binant factor VIIa product was used to promote haemostasis in 13 surgi
cal procedures. Due to a short in vivo half-life of activated factor V
IIa, frequent administration was scheduled, injecting factor VIIa ever
y 2-3 h for up to 2 days after which dosage intervals were prolonged.
In one case, a global evaluation of the end treatment result was not r
eported, but in all of the other 12 cases the end result were consider
ed excellent (n = 11) or efficient (n = 1). In none of the cases was o
ther types of coagulation factor treatment modalities necessary. In co
nclusion, recombinant factor VIIa seems a tempting alternative to trad
itional treatment of the haemophilic patient with inhibitors, in whom
surgery is called for. With other types of haemostatic agents, surgery
in haemophilic inhibitor patients has only been studied rarely, and o
perations have generally been restricted to life-threatening situation
s.