Safety of Recombinant Activated Factor VII in Randomized Clinical Trials

Levi, Marcel; Levy, Jerrold H.; Andersen, H.; Truloff, David

doi:10.1056/nejmoa1006221

Cited by 626 publications

(378 citation statements)

References 39 publications

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“…55 Unfortunately, the majority of trials have thus far been underpowered to clarify the true risks. Furthermore, the underlying causes of TAEs when rFVIIa has been used off-label remain unclear.…”

Section: Discussionmentioning

confidence: 99%

Recombinant Factor VIIa: An Assessment of Evidence Regarding Its Efficacy and Safety in the Off-Label Setting

Logan

Goodnough

2010

Hematology

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Recombinant human factor VIIa (rFVIIa) is approved by the US Food and Drug Administration for use in the setting of hemorrhage associated with factor VIII or factor IX inhibitors in patients with congenital or acquired hemophilia. This indication represents only a small number of bleeding conditions. Since it became available, rFVIIa has been increasingly used in the management of off-label indications, ranging from emergent hemostasis in traumatic hemorrhage to prophylactic hemostasis in patients undergoing major surgery. Prominent off-label indications include the management of patients with coagulopathies, such as occurs in trauma patients experiencing massive and uncontrolled hemorrhage, and in patients undergoing cardiovascular surgery with cardiopulmonary bypass. Other occasions for use occur in patients with intact coagulation systems, with nontraumatic intracranial hemorrhage being the most common in this group. Uncertainties regarding the efficacy and safety associated with use of rFVIIa in these off-label scenarios have led to evidence-based assessments of patient outcomes, including mortality, the rate of thromboembolic adverse events, and posttreatment functional status. We review the evidence regarding the efficacy and safety of this important, but controversial, hemostatic agent in the off-label setting.

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Section: Discussionmentioning

confidence: 99%

Recombinant Factor VIIa: An Assessment of Evidence Regarding Its Efficacy and Safety in the Off-Label Setting

Logan

Goodnough

2010

Hematology

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“…46 Particularly, recent meta-analyses of clinical trials have questioned the efficacy of offlabel recombinant activated factor VII in reducing bleeding 49 and concluded that the off-label use at high doses increases the risk of thromboembolic events. 50 Another systemic approach to minimize blood loss is avoiding hypothermia (if not otherwise indicated), as hypothermia can adversely affect platelet function and result in increased blood loss. 17 Even mild perioperative hypothermia has been reported to be associated with increased blood loss and risk of transfusion.…”

Section: Intraoperative Managementmentioning

confidence: 99%

From Bloodless Surgery to Patient Blood Management

Shander

Javidroozi

Perelman

et al. 2012

Mount Sinai J Medicine

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Safety and efficacy concerns of allogeneic blood transfusions and their impact on patient outcomes and associated staggering costs and restricted supply have fueled the quest for other modalities and strategies to reduce use of blood components. Patient blood management focuses on multidisciplinary and multimodal preventive measures to reduce or obviate the need for transfusions and ultimately to improve the clinical outcomes of patients. Patient blood management strategies can be applied at every stage of care to surgical and nonsurgical patients, and they Address

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“…Data from 35 randomized clinical trials of off-label indications for rFVIIa versus placebo (26 studies involving patients and nine studies involving healthy volunteers) were analysed to determine the frequency of thromboembolic events [3]. Most of the clinical trials were Novo Nordisk-sponsored studies (29 vs. 6 investigator-initiated trials).…”

Section: Discussionmentioning

confidence: 99%

Off-label use of recombinant activated coagulation factor VII for bleeding may raise the risk of arterial thrombosis

Ferrari

Podda

2011

Intern Emerg Med

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Safety of Recombinant Activated Factor VII in Randomized Clinical Trials

Abstract: In a large and comprehensive cohort of persons in placebo-controlled trials of rFVIIa, treatment with high doses of rFVIIa on an off-label basis significantly increased the risk of arterial but not venous thromboembolic events, especially among the elderly. (Funded by Novo Nordisk.).

Cited by 626 publications

References 39 publications

Recombinant Factor VIIa: An Assessment of Evidence Regarding Its Efficacy and Safety in the Off-Label Setting

Recombinant Factor VIIa: An Assessment of Evidence Regarding Its Efficacy and Safety in the Off-Label Setting

From Bloodless Surgery to Patient Blood Management

Off-label use of recombinant activated coagulation factor VII for bleeding may raise the risk of arterial thrombosis

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