The use of recombinant factor VIIa in controlling surgical bleeding in non-haemophiliac patients.

Recombinant factor VIIa (rFVIIa, NovoSeven) is effective and appears safe in the management of bleeding episodes and provision of surgical cover in haemophilia patients with inhibitors. Additionally, rFVIIa has been considered as a universal haemostatic agent, prompting its use in the management of severe uncontrolled surgical bleeding in patients without pre-existing coagulopathies. Recombinant FVIIa has been used in 5 patients (aged 2.5 to 73.0 years; median 48 years) with uncontrolled bleeding during or after open-heart surgery. Satisfactory haemostasis was achieved with a single dose or rFVIIa 30 microg/kg, that resulted in reduction of blood loss from a mean of 4,170 ml (650-8,000 ml) to 262.5 ml (220-334 ml). No significant adverse events were reported. Recombinant FVIIa was also successfully used in controlling post-surgical bleeding in two patients with Crohn's disease, one patient with bleeding duodenal ulcer and another with false thoracic aneurysm. It was also effective in controlling bleeding post-splenectomy in a patient with chronic myeloid leukaemia, and following anterior exenteration in a patient with cervical carcinoma. A randomised study comparing the efficacy of a single perioperative dose of rFVIIa with placebo in patients undergoing transabdominal prostatectomy was conducted by Levi and colleagues [6]. An interim analysis showed a significant reduction in mean blood loss from 2,450 +/- 350 ml to 1,400 +/- 190 ml between placebo and rFVIIa groups respectively (p = 0.007). Among trauma patients, Kenet et al. reported success in treating uncontrolled bleeding from a gun-shot wound to the inferior vena cava, using two doses of rFVIIa 60 microg/kg [7]. This treatment has subsequently been used in 6 surgical patients with uncontrolled bleeding and in 7 cases of traumatic bleeding, with remarkable results. In conclusion, rFVIIa appears to be effective and safe in the management of uncontrolled surgical and traumatic haemorrhage in patients not known to have inherited coagulopathy. Copyright 2002 S. Karger AG, Basel

RCT Entities:   Population Interventions Outcomes