Clinical experiences and current evidence for therapeutic recombinant factor VIIa treatment in nontrauma settings

R Michael Grounds,Charles Bolan

doi:10.1186/cc3783

Abstract

The hemostatic properties of recombinant activated factor VII (rFVIIa) are established in patients with inherited or acquired hemophilia with inhibitors and in patients with congenital factor VII deficiencies. Emerging clinical evidence suggests that there may be a wider role for rFVIIa in the management of hemorrhage associated with traumatic injury/accident and severe bleeding associated with critical surgery. This article considers recent data from studies in which rFVIIa was used in an attempt to control bleeding in clinical situations as diverse as coagulopathy associated with chronic liver disease, massive perioperative bleeding and bleeding during prostatectomy, organ transplantation and orthopedic surgery, uncontrollable obstetric hemorrhage, and intracerebral hemorrhage. In nontrauma settings involving acute and potentially life threatening bleeding, there may be a place for rFVIIa as adjunctive therapy in the control of hemostasis.

Highlights

Since the first reports of hemostatic responses in trauma patients with uncontrolled hemorrhage [1,2], a growing body of literature has addressed the use of recombinant activated factor VII in settings outside the therapy of hemophilia patients with high titer inhibitors
As in the setting of acute trauma, significant issues of cost, indications, laboratory monitoring, safety, optimal dose, and use with blood products and other hemostatic agents remain to be established for rFVIIa use in patients without acute trauma who do not have hemophilia
In this report we review these issues for clinical conditions that are likely to be encountered in the operating theatre or intensive care unit

Summary

Introduction

Since the first reports of hemostatic responses in trauma patients with uncontrolled hemorrhage [1,2], a growing body of literature has addressed the use of recombinant activated factor VII (rFVIIa – NovoSeven®; Novo Nordisk A/S, Bagsværd, Denmark) in settings outside the therapy of hemophilia patients with high titer inhibitors. RFVIIa may be useful in patients who urgently require FFP but have clinically documented significant IgA deficiency, in severely HLAalloimunized thrombocytopenic patients who lack commonly available donors or in patients with rare RBC types or with multiple red cell alloantibodies who are undergoing surgery S34 and other invasive procedures, in whom standard blood product transfusion may be ineffective or dangerous In these cases, practicality and cost profiles change, and treatment may be necessary in the absence of the usual standard therapies. Despite the promise of this initial study, current best practice should involve very cautious use of this agent in DIC, active thrombosis, vascular grafts with endothelial injury, or other conditions at risk for thrombotic sequelae

Conclusion

Poon MC

Findings

15. Planinsic RM