Effect of Recombinant Activated Factor VII in Critical Bleeding: Clinical Experience of a Single Center

Abstract

Recombinant activated factor VII (rFVIIa) has been successfully used ''off-label'' in patients with refractory life-threatening hemorrhage. Intravenous rFVIIa was given to 31 patients unresponsive to standard therapy with blood products and surgical reexploration, who were bleeding due to trauma, surgery, organ transplantation, liver cirrhosis, ruptured uterus. We recorded their coagulation and hematologic profiles, acid-base balance, blood loss, number of red blood cells (RBC), plasma and platelet transfusions, complications, and survival. rFVIIa (mean dose 132.2 +/- 56.3 microg/kg) effectively contained the hemorrhage in 28/31 (90.3%) cases, with a mean reduction in blood loss from 12.4 +/- 10.2 to 2.7 +/- 2.2 L (P < .0001). The need for RBC, platelet, and plasma transfusion decreased significantly after rFVIIa, with a consequent significant improvement in clotting of test hematocrit, pH, and bicarbonates. Four patients had adverse events potentially related to rFVIIa. The survival rates after 1 and 30 days were 48.4% and 29.1%, respectively.

Dabigatran bleed risk with closed head injuries: are we prepared?

“…20 Our review of the current literature and preclinical studies suggests that future management options may include the use of activated charcoal, hemodialysis, and administration of rFVIIa and/or PCC. 12,20 On the basis of the mean concentration differences, the mean fraction of dabigatran removed by dialysis was 62% at 2 hours and 68% at 4 hours. 15 In their own pharmaceutical insert, the manufacturer (Boehringer Ingelheim Pharmaceuticals) suggests the use of FFP and/or packed red blood cells.…”

“…Several studies assessing the risk of major bleeding complications have shown dabigatran to have a reduced amount of risk compared with other anticoagulants. 12,14,18,21 However, the lack of guidelines, protocols, and an established specific antidote to reverse the anticoagulation effect of dabigatran potentially increases morbidity and mortality in patients with CHI. Confronted with this new problem, we reviewed our initial clinical experience.…”

Antithrombotic Therapy in Atrial Fibrillation - Evaluation and Positioning of New Oral Anticoagulant Agents -

“…Recombinant activated factor VII (rFVIIa; NovoSeven ® , Novo Nordisk, Bagsvaerd, Denmark) 55 and prothrombin complex concentrates 56 can also be useful to rapidly reverse coagulopathy. However, there are no published clinical data on the use of these agents in patients receiving dabigatran and information is limited for the other new oral anticoagulants.…”

Balancing Efficacy and Bleeding Risk in the Prevention of Stroke Due to Atrial Fibrillation with Newer Oral Anticoagulants

“…As a result, it has been proposed that this agent may have potential in reversing the effects of a variety of anticoagulants, including the new oral thrombin inhibitors. It has been successfully used ''off-label'' in patients with refractory life-threatening haemorrhage [21].…”