Efficacy of recombinant activated Factor VII in patients with massive uncontrolled bleeding: a retrospective observational analysis

Abstract

This study suggests that rFVIIa may play a role in patients with massive uncontrolled blood loss by reducing the amount of RBC and FFP transfusions and by improving the coagulation variables.

Low-dose recombinant factor VIIa for massive bleeding: A single centre observational cohort study with 73 patients

“…As for rFVIIa dose, among patients with central nervous system bleeding who received rFVIIa, there was a significant correlation between dose and rates of arterial thromboembolic events [22]. Although many publications on off-label use of rFVIIa reported an effective median dose similar to that of standard indications, 90 μg/kg body weight [4,23], or even much higher, up to 200 μg/kg body weight [10], there are some studies indicating a therapeutic effect already at lower doses, in particular in certain indications, such as acute intracerebral haemorrhage [8], traumatic bleeding [11,12], retropubic prostatectomy [15] or cardiac surgery [24,25]. In 2004, we had chosen to employ for off-label use at our institution a low rFVIIa dose of 60 μg/kg because it leads to a plasmatic rFVIIa concentration which still is 5-6 times higher than the minimal effective level [26], and because high rFVIIa doses could theoretically lead to excessive thrombin generation with consecutive activation of the anticoagulant protein C pathway by means of thrombin binding thrombomodulin [27].…”

The Effect of Intravenous Administration of Active Recombinant Factor VII on Postoperative Bleeding in Cardiac Valve Reoperations; A Randomized Clinical Trial

“…Therefore, the results of our study were in concordance with some other studies in which rFVIIa was used as a prophylactic agent, although none were in redo cardiac surgeries. In addition, as mentioned in other studies, rFVIIa could be used both as a prophylactic agent and as a "rescue therapy" in order to treat refractory bleeding; however, there are some controversies on that regard ( 1 , 5 , 10 , 17 , 18 , 28 , 29 , 34 - 39 ). Gill et al performed a randomized placebo-controlled trial in those with bleeding after cardiac surgery; they observed more critical adverse events in the rFVIIa groups (40 and 80 µg/kg) than in placebo group although it was statistically insignificant.…”

“…The cause of post-cardiac surgery bleeding can be either surgical or nonsurgical ( 1 - 4 ). Microvascular diffuse bleeding after cardiac surgery is still considered as an important and common problem leading to the use of antifibrinolytic drugs; however, the efficacy of these drugs is not always the same ( 1 - 10 ).…”

Blood utilization: fostering an effective hospital transfusion culture

“…Some institutions have developed policies and guidelines for rFVIIa use, recommending caution in administering to patients at increased risk for thrombotic complications, ie, history of coronary artery disease, cerebral vascular disease, or venous or arterial thrombosis, DIC, those receiving extracorporeal membrane oxygenation or on ventricular assist device, or following cardiac surgery [34]. Nevertheless, a recent retrospective observational analysis of patients treated with rFVIIa for massive bleeding noted significantly reduced transfusion requirements, improved coagulation variables, and a 56% survival rate [35]. Another study found that treatment with rFVIIa within 4 hours of onset of intracerebral hemorrhage limited growth of the hematoma, reduced mortality, and improved functional outcomes at 90 days, despite a small increase in thromboembolism [36].…”