Hémorragie de la délivrance « menaçant la vie » et utilisation du facteur VII recombinant activé rFVIIa NovoSeven®

Courtois, Luc; Becher, P.; Miot, S.; Maisonnette-Escot, Y.; Sautière, J.-L.; Berthier, Françoise; Samain, Emmanuel; Maillet, R; Riethmuller, Didier

doi:10.1016/j.jgyn.2006.09.002

Journal de Gynécologie Obstétrique et Biologie de la Reproducti

2007

DOI: 10.1016/j.jgyn.2006.09.002

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Hémorragie de la délivrance « menaçant la vie » et utilisation du facteur VII recombinant activé rFVIIa NovoSeven®

Luc Courtois

P. Becher

S. Miot

et al.

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Cited by 5 publications

(2 citation statements)

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“…In 1999, the US Food and Drug Administration approved its use for the treatment of bleeding episodes in patients with hemophilia and in patients with factor VIII or factor IX inhibitors 1–3. The success of rFVIIa in controlling hemophiliac bleedings has led to its use for other serious bleeding episodes, such as in non-hemophiliac patients with active bleeding and as a prophylactic agent for high-risk patients with obstetrical bleeding,4–8 hemorrhage associated with warfarin toxicity,910 intracerebral hemorrhage,11–12 upper gastrointestinal bleeding,1314 intractable bleeding after cardiopulmonary bypass in children and adults and Glanzmann's thrombocytopenia 15–18…”

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Recombinant activated factor VII in controlling bleeding in non-hemophiliac patients

Algahtani

Alshaikh

AlDiab

2010

Annals of Saudi Medicine

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BACKGROUND:There have been recent reports on the successful use of recombinant factor VIIa (rFVIIa) in non-hemophiliac patients who have experienced heavy blood loss due to trauma with extensive organ damage and who have received multiple blood transfusions with hemostatic changes without success. The timing of administration, dosage, mortality, units of blood transfusion saved, risk of thrombotic events, and the risk/benefit ratio are still poorly defined.PATIENTS AND METHODS:We conducted a retrospective review of all medical records of patients who received rFVIIa between January 2003 and March 2008. Data collection included demographic characteristics, diagnosis, indications, comorbidities, and amount of blood products used with rFVIIa, dose of rFVIIa, mortality, and adverse events.RESULTS:We identified 45 patients, 27 (60%) males and 18 (40%) females, with a median age of 52 years. The median dose of rFVIIa was 40 μg/kg (range, 20-120 μg/kg). Five (11.1%) patients needed a second dose of rFVIIa (dose range of 20-85 μg/kg) whereas three patients (6.7%) needed a third dose of rFVIIa (dose range of 40-60 μg/kg). There was a marked and significant reduction in transfusion requirements for packed red blood cells (P=.0078). Overall transfusion requirements significantly decreased after the infusion of rFVIIa (P=.0323). Nineteen patients (42.2%) died and thrombosis was documented in 3 patients (6.7%).CONCLUSION:Use of rFVIIa should be based on sound clinical evidence to balance the risks, benefits, and cost if used among non-hemophiliacs. Prospective randomized studies are needed to investigate the efficacy and cost-effectiveness of rFVIIa for this indication and to allow a final assessment of the importance of this treatment.

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“…Several studies have reported the “off-label” use of rFVIIa 5–810–151718. Only two randomized, placebo-controlled, double-blind trials were conducted to evaluate the efficacy and safety of rFVIIa among trauma patients with massive bleeding 19.…”

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Recombinant activated factor VII in controlling bleeding in non-hemophiliac patients

Algahtani

Alshaikh

AlDiab

2010

Annals of Saudi Medicine

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Pulmonary embolism after administration of recombinant activated Factor VII for major obstetric hemorrhage

McCarthy

Allen

Habib

2012

Journal of Clinical Anesthesia

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Uso compasivo de factor VIIa recombinante en pacientes con hemorragia grave

2010

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Hémorragie de la délivrance « menaçant la vie » et utilisation du facteur VII recombinant activé rFVIIa NovoSeven®

Cited by 5 publications

References 22 publications

Recombinant activated factor VII in controlling bleeding in non-hemophiliac patients

Recombinant activated factor VII in controlling bleeding in non-hemophiliac patients

Pulmonary embolism after administration of recombinant activated Factor VII for major obstetric hemorrhage

Uso compasivo de factor VIIa recombinante en pacientes con hemorragia grave

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