Use of Activated Recombinant Factor VII in Severe Bleeding – Evidence for Efficacy and Safety in Trauma, Postpartum Hemorrhage, Cardiac Surgery, and Gastrointestinal Bleeding

Abstract

Background: Uncontrolled bleeding continues to be a major cause of mortality in trauma, cardiac surgery, postpartum hemorrhage and liver failure. The aim of this paper is to assess the evidence supporting the efficacy of activated recombinant factor VII (rFVIIa) administration in these settings. Methods: Electronic literature search. Results: Numerous retrospective trials have mostly shown a decrease in blood transfusion requirements with no increase in thromboembolic events (TEE), but major limitations in trial design make generalization difficult. In most retrospective reports rFVIIa has been administered as a last-ditch attempt to control bleeding, when acidosis, hypothermia and coagulation factor depletion may not allow optimal rFVIIa effect. Prospective randomized controlled trials have not shown any effect of rFVIIa on mortality or TEE, although some have shown a reduction in RBC requirement. Conclusion: Stipulated transfusion protocols in prospective trials have reduced anticipated mortality among controls and make future trials for mortality effect unlikely in view of large sample size requirements. Establishment of these protocols and rapid hemostasis are likely to have greater benefits than administration of a single agent.

Role of intensive care in management of post-partum hemorrhage (PPH)

“…A study reported thrombosis as an adverse effect following its use in cardiac surgery however its occurrence in obstetric practice is rare. 24…”

Optimizing Blood Transfusion Service Delivery across the West African Sub-Region

“…The recombinant activated factor VII (FVII, rFVIIa, FXIII), prothrombin complex concentrates (PCC) and antifibrinolytics (tranexamic acid, epsilon aminocaproic acid and aprotinin) have been used for the management of traumatic bleeding [110] and found to produce a reduction in RBC use but not necessarily improvement in mortality. More recently, viscoelastic assays (rotational thromboelastometry -ROTEM or thromboelastography-TEG) have been advocated [111]. Early recognition of a coagulopathy and subsequent monitoring is vital to both initiate and maximize resuscitation therapy.…”

Current Concepts in the Treatment of Major Obstetric Hemorrhage

“…In these studies, rFVIIa was given for MOH of different etiology, at different doses and at non-uniform intervals [83,84]. Also, administration of rFVIIa has the potential disadvantage of causing serious thromboembolism in the obstetric population when administered during massive hemorrhage [85,86]. Given the lack of data supporting the use of rFVIIa, its high cost, and the side effects described above, it is hard to support its routine use for treatment of major obstetric hemorrhage.…”