Efficacy of recombinant activated factor VII (rFVIIa; NovoSeven^®) in obstetrical haemorrhagic shock

Background

Recombinant factor VII (rFVIIa) (NovoSeven^®; Novo Nordisk, Denmark) is mainly indicated for treatment of the patients with haemophilia and inhibitors in the control of perioperative and spontaneous bleeding. However, no information is available on the use of rFVIIa in the treatment of severe and recurrent bleeding and its complications in the obstetrical patients. Treatment difficulties of hemorrhagic shock arise from coagulopathy coexistence. Therefore, the use of rFVIIa in patients suffering from uncontrolled haemorrhage appears to be rational.

Methods

We report 15 cases of obstetrical hypovolaemic shock (after massive bleeding) in ATLS classification between II and IV category (class) with coagulopathy coexistence. After the failure of conventional methods of therapy, they were treated with small doses of rFVIIa (median, 18 μg/kg; range, 16.7–48 μg/kg) to achieve haemostasis.

Results

The rapid response after administration of rFVIIa resulted in cessation of the diffuse bleeding (in 78.6% bleeding was completely stopped, in the remaining 21.4% it weakened relevantly) with significant limitation of supplemented blood products; red cell concentrate from 2100 ml to 1236 ml (P < 0.05); fresh frozen plasma from 1000 ml to 490 ml (P < 0.05) and good coagulologic control; shortening of prothrombin time and activated partial thromboplastin time from 16.5 s (range, 9.3–25.2 s) to 11.1 s (range, 9.1–20.2 s) (P < 0.001) and 52.5 s (range, 26.1–80.2 s) to 32.75 s (range, 25.9–75.8 s) (P < 0.001), respectively. In four cases of uterine atony, the hysterectomy was not necessary after rFVIIa applications. No side effects related to use of rFVIIa were noted.

Conclusion

The results of our study suggest that, in obstetrical hypovolaemic shock after massive bleeding and coagulopathy, rFVIIa may play a role as an adjunctive haemostatic agent in these cases where the surgical haemostasis was adequate.