1.
Evidence supporting the use of recombinant activated factor VII in congenital bleeding disorders
Johansson PI, Ostrowski SR
Drug Design, Development & Therapy. 2010;4:107-16.
Abstract
BACKGROUND Recombinant activated factor VII (rFVIIa, NovoSeven) was introduced in 1996 for the treatment of hemophilic patients with antibodies against coagulation factor VIII or IX. OBJECTIVE To review the evidence supporting the use of rFVIIa for the treatment of patients with congenital bleeding disorders. PATIENTS AND METHODS English-language databases were searched in September 2009 for reports of randomized controlled trials (RCTs) evaluating the ability of rFVIIa to restore hemostasis in patients with congenital bleeding disorders. RESULTS Eight RCTs involving 256 hemophilic patients with antibodies against coagulation factors, also known as inhibitors, were identified. The evidence supporting the use of rFVIIa in these patients was weak with regard to dose, clinical setting, mode of administration, efficacy, and adverse events, given the limited sample size of each RCT and the heterogeneity of the studies. CONCLUSION The authors suggest that rFVIIa therapy in hemophilic patients with inhibitors should be based on the individual's ability to generate thrombin and form a clot, and not on the patient's weight alone. Therefore, assays for thrombin generation, such as whole-blood thromboelastography, have the potential to significantly improve the treatment of these patients.
2.
Recombinant Factor VIIa decreases perioperative blood transfusion requirement in burn patients undergoing excision and skin grafting--results of a single centre pilot study
Johansson PI, Eriksen K, Nielsen SL, Rojkjaer R, Alsbjorn B
Burns. 2007;33((4):):435-40.
Abstract
BACKGROUND Excision of burn wounds is frequently associated with a large volume of blood loss requiring allogeneic blood transfusion. We conducted a pilot study to investigate the effect of activated recombinant coagulation factor VII (rFVIIa) on the reduction of blood transfusion requirements in burn patients undergoing excision and skin grafting. METHODS Eighteen consecutive patients scheduled for the surgery were randomised to receive either placebo or 40 microg/kg rFVIIa administered at first skin incision, and a second dose (40 microg/kg) at 90 min later. Blood transfusion requirements during, and up to 24h post-surgery per patient and percentage full thickness wound excised were compared. In addition, postoperative complications commonly seen in patients with burns as well as adverse events related to rFVIIa were monitored. RESULTS rFVIIa significantly decreased the total number of units of blood components transfused per patient and percentage full thickness burn wound excised compared with placebo (0. 9 versus 2. 2, p=0. 0013) including significant fewer red blood cell units (0. 5 versus 1. 1, p=0. 004). We further observed a trend towards improved graft survival (p=0. 1) and a reduction in multiple organ failures (p=0. 08) in the rFVIIa-treated group. There were no adverse events, in particular thromboembolic events. CONCLUSION rFVIIa might be useful in decreasing blood transfusion requirements in burn patients undergoing excision and skin grafting.