USE OF RECOMBINANT FACTOR VIIA IN SURGERY IN FACTOR-VII-DEFICIENT PATIENTS

Patients suffering from severe factor VII deficiency may present with serious bleeding problems. No clear guidelines exist regarding therapy in such patients in case of a large bleeding or surgery. Indeed, it h as been postulated that some patients with severe factor VII deficienc y may never present with overt bleeding problems. However, in factor-V II-deficient patients who have previously demonstrated a clinical tend ency to bleed, surgery is expected to cause excessive bleeding. We pre sent two females suffering from a severe factor VII deficiency (FVII:C < 0.01 U mL(-1)) with a distinct history of haemorrhagic diathesis. D ue to recurrent bleeding in the past, or for circumstantial reasons, s urgery was demanded over a 4-year period on a total of seven occasions . To assist haemostasis during and after joint surgery on five occasio ns and for embolization and subsequent removal of a large haemangioma of the occipital region, recombinant factor VIIa (NovoSeven) was utili zed in doses approximating 20 mu g kg(-1) b.w. every 6 h beginning imm ediately before surgery and continued until 30 h to 13 days postoperat ively, depending of the size of the respective procedure. Using this a pproach, we observed normal haemostasis, and there were no signs of ex cessive postoperative bleeding or wound haematoma. No adverse reaction s or side-effects were observed, and there were no complaints or clini cal signs indicative of thrombotic complications. As judged from the c linical course of these seven minor and major surgeries, recombinant f actor VIIa appears to be highly efficaceous and safe in the treatment patients with severe factor VII deficiency undergoing surgery.