Recombinant factor VIIA

Question 1

What is the approved use of recombinant Factor VIIa (rFVIIa)?

Answer 1

For hemophiliacs with inhibitors to Factor VIII or IX.

Question 2

What is the mechanism of action of rFVIIa?

Answer 2

• Binds to exposed tissue factor at endothelial injury.
• Activates platelets → platelet plug formation.
• Stimulates thrombin generation → promotes coagulation cascade.
• Inhibits fibrinolysis via thrombin activatable fibrinolysis inhibitor (TAFI).

Question 3

What is the role of rFVIIa in trauma-related hemorrhage?

Answer 3

• Shown to reduce hemorrhage severity in blunt trauma.
• No transfusion-sparing effect in penetrating trauma.

Question 4

What was the outcome of the CONTROL trial on rFVIIa use in trauma?

Answer 4

• Stopped early for futility.
• Control arm had lower-than-expected mortality.
• No mortality benefit shown for rFVIIa.

Question 5

What are the limitations of rFVIIa use in clinical settings?

Answer 5

• High cost.
• No proven mortality benefit.
• Associated with thrombotic events.
• Alternative options available (e.g., Prothrombin Complex Concentrate - PCC).

Question 6

Thromboembolic events with Factor VIIA

Answer 6

M/C when used off label
Incidence- 0.02% in haemophiliacs

MI, Stroke, PE- upto 8% when used in other populations

Equal incidence of Arterial and venous thrombi

But increased incidence not backed by evidence- CONTROL trial which did not find any difference in complications between trauma patients who did and did not receive factor VIIa