Skip to main content

The Risk of Thromboembolic Events in the Use of Recombinant Activated Factor VII to Control Bleeding in Nonhemophiliac Patients With Spontaneous Intracerebral Hemorrhages: A Systematic Review

14 August 2010


Background: Intracerebral hemorrhage is a devastating event that may occur spontaneously or as the result of a trauma. Anticoagulation-related hemorrhages are increasing with the growing number of patients on oral anticoagulation therapy. Off label use of recombinant activated factor VIIa (rFVIIa) is effective in lowering the INR, thus rapidly decreasing the risk of hematoma expansion and allowing for faster response when emergent surgery is indicated. rFVIIa, currently approved by the FDA for use in hemophiliac patients only, has been demonstrated to quickly reverse the effects of anticoagulation therapy, with the additional benefit of reducing further hematoma growth. However, it’s not without complications. rFVIIa has been reported as increasing the occurrence of post treatment thromboembolic events. This review will assess published studies that have evaluated the safety of rFVIIa in non-hemophiliac patients presenting with acute spontaneous intracerebral hemorrhages.

Methods: A systematic review of the past 6 years of English-language published literature was conducted using MEDLINE, CINAHL, and a multi-resource EBM database using keywords rFVIIa, thromboembolic events, intracerebral hemorrhage and subordinate headings. Articles that examined safety with the use of rFVIIa in non hemophiliac patients to manage spontaneous intracerebral hemorrhages were selected. Five studies were analyzed for quality and noteworthy results.

Results: These studies have demonstrated that the risk of thromboembolic events at low doses, < 80 μg/kg of rFVIIa, is comparable to that of a placebo. Simultaneously, they have demonstrated that with higher doses, ≥ 80 μg/kg of rFVIIa, in high-risk patients, occurrence of thromboembolic events increases substantially.

Conclusion: These findings suggest that it would be appropriate at this time to pursue further investigations comparing the safety and efficacy of rFVIIa with that of Vitamin K and FFP in well-designed, randomized controlled trials in addition to studies that include patients on oral anticoagulant therapy.


File nameDate UploadedVisibilityFile size
Main File
19 Mar 2020
370 kB