The effect of recombinant factor VIIa (NovoSeven???) in healthy volunteers receiving acenocoumarol to an International Normalized Ratio above 2.0

Erhardtsen, Elisabeth; Nony, Patrice; Dechavanne, M; Ffrench, Patrick; Boissel, Jean-Pièrre; Hedner, Ulla

doi:10.1097/00001721-199811000-00003

Cited by 170 publications

(118 citation statements)

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“…Therefore, faster correction of INR may not necessarily translate to faster correction of coagulopathy. However, FVIIa also increases the plasma activities of factors IX and X in a dose-dependent manner (20). Observations of our patients and several previously published case series have demonstrated the efficacy of FVIIa in normalizing the INR as well as in stopping bleeding in a variety of clinical situations, including bleeding associated with excessive anticoagulation (9,(11)(12)(13).…”

Section: Discussionsupporting

confidence: 66%

Use of Recombinant Factor VIIa in Patients With Warfarin-Associated Intracranial Hemorrhage

Brody

Aiyagari

Shackleford

et al. 2005

NCC

132

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Section: Discussionsupporting

confidence: 66%

Use of Recombinant Factor VIIa in Patients With Warfarin-Associated Intracranial Hemorrhage

Brody

Aiyagari

Shackleford

et al. 2005

NCC

132

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“…It has been reported that rFVIIa normalises the INR in anticoagulated volunteers. 52 In 13 warfarinised patients requiring urgent reversal, INR normalisation was achieved using rFVIIa (dose range, 15-90 mg/kg). 53 Small numbers of patients with ICH successfully treated with rFVIIa have been reported recently.…”

Section: Is There a Role For Rfviia In Rapid Warfarin Reversal?mentioning

confidence: 99%

Warfarin reversal

2004

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Warfarin is the most commonly used oral anticoagulant in the UK. It is associated with few side effects apart from haemorrhage. The most appropriate way to reverse the anticoagulant effect of warfarin depends on the clinical circumstances. In serious bleeding, rapid reversal is required, whereas in minor bleeding or asymptomatic over anticoagulation, a more leisurely approach is usually appropriate. This review discusses the current approaches to warfarin reversal in clinical practice. The development of a uniform approach to warfarin reversal in the Northern Region is described.

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“…Fondaparinux has a biological half-life of Ϸ17 hours, and a strategy to reverse the anticoagulant state in case of life-threatening bleeding or for acute surgery appears desirable. A candidate for reversal of the anticoagulant effect of fondaparinux is recombinant factor VIIa (rFVIIa), which has the ability to normalize prothrombin times in subjects taking warfarin 13 and to restore thrombin generation during inhibition of the tissue factor-factor VIIa complex. 14 Thus, we investigated in healthy male volunteers whether rFVIIa is able to neutralize the anticoagulant effect of 10 mg of fondaparinux, which is 4 times the dose used in prophylactic treatment of venous thromboembolism.…”

mentioning

confidence: 99%

Ability of Recombinant Factor VIIa to Reverse the Anticoagulant Effect of the Pentasaccharide Fondaparinux in Healthy Volunteers

et al. 2002

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Background-The novel anticoagulant fondaparinux proved to be effective and safe in the postoperative prevention of venous thrombosis. Current phase III trials with this synthetic selective factor Xa inhibitor focus on its use in the treatment of patients with venous and arterial thrombosis. As with any anticoagulant therapy, there is a risk of bleeding complications; hence, a strategy to reverse the effects of fondaparinux is desirable. The aim of this study was to investigate whether recombinant factor VIIa (rFVIIa) could neutralize the anticoagulant effects of subcutaneously administered fondaparinux. Methods and Results-In a randomized, placebo-controlled design, 16 healthy male subjects received either a single subcutaneous dose of fondaparinux (10 mg) and a single intravenous bolus of rFVIIa (90 g/kg; nϭ8), fondaparinux and placebo (nϭ4), or placebo and rFVIIa (nϭ4). Fondaparinux (or placebo) was administered 2 hours before rFVIIa (or placebo). Injection of rFVIIa after fondaparinux normalized the prolonged activated partial thromboplastin and prothrombin times and reversed the decrease in prothrombin activation fragments 1ϩ2 (F 1ϩ2 ), as observed with fondaparinux alone. Thrombin-generation time and endogenous thrombin potential, which were inhibited by fondaparinux, normalized up to 6 hours after rFVIIa injection. Conclusions-rFVIIa is capable of normalizing coagulation times and thrombin generation during fondaparinux treatment.The duration of this effect ranged from 2 to 6 hours after rFVIIa injection. These results suggest that rFVIIa may be useful to reverse the anticoagulant effect of fondaparinux in case of serious bleeding complications or need for acute surgery during treatment with fondaparinux.

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The effect of recombinant factor VIIa (NovoSeven???) in healthy volunteers receiving acenocoumarol to an International Normalized Ratio above 2.0

Cited by 170 publications

References 0 publications

Use of Recombinant Factor VIIa in Patients With Warfarin-Associated Intracranial Hemorrhage

Use of Recombinant Factor VIIa in Patients With Warfarin-Associated Intracranial Hemorrhage

Warfarin reversal

Ability of Recombinant Factor VIIa to Reverse the Anticoagulant Effect of the Pentasaccharide Fondaparinux in Healthy Volunteers

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