Recombinant human FVIIa for reducing the need for invasive second-line therapies in severe refractory postpartum hemorrhage: a multicenter, randomized, open controlled trial

Autor: A. Mignon, Géraldine Lavigne-Lissalde, E. Morau, Céline Chauleur, S. Bouvet, A. Bongain, S. Roger-Christoph, P. De Moerloose, A.G. Aya, F.J. Mercier, Jean-Christophe Gris, Pascale Fabbro-Peray, A.-S. Ducloy-Bouthors, M. Raucoules, Françoise Boehlen
Přispěvatelé: Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Caractéristiques féminines des dysfonctions des interfaces cardio-vasculaires (EA 2992), Université Montpellier 1 (UM1)-Université de Montpellier (UM), Service d'anesthésie [Béclère], Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Antoine Béclère [Clamart], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital privé d’Antony, CHU Saint-Etienne, Groupe de recherche sur la thrombose (GRT (EA 3065)), Université Jean Monnet [Saint-Étienne] (UJM), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Unité de Soins Intensifs [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Centre Hospitalier Universitaire de Nice (CHU Nice), Hôpital Universitaire de Genève, BESPIM, Aide à la Décision pour une Médecine Personnalisé - Laboratoire de Biostatistique, Epidémiologie et Recherche Clinique - EA 2415 (AIDMP)
Jazyk: angličtina
Rok vydání: 2015
Předmět:
Compassionate Use Trials
Time Factors
FVIIa activated
Deep vein
Factor XIIa
Severity of Illness Index
law.invention
Second line
treatment efficacy
Randomized controlled trial
law
Pregnancy
Risk Factors
Venous Thrombosis/chemically induced
Treatment Failure
hysterectomy
Infusions
Intravenous
ComputingMilieux_MISCELLANEOUS
Venous Thrombosis
ddc:616
[SDV.MHEP.HEM]Life Sciences [q-bio]/Human health and pathology/Hematology
Hematology
Delivery mode
Thrombosis
Postpartum Hemorrhage/diagnosis/drug therapy/mortality
3. Good health
Pulmonary embolism
medicine.anatomical_structure
postpartum hemorrhage
Female
France
Switzerland
Adult
medicine.medical_specialty
macromolecular substances
Hysterectomy
Coagulants/administration & dosage/adverse effects/therapeutic use
Dinoprostone
Drug Administration Schedule
Factor VIII/administration & dosage/adverse effects/therapeutic use
Refractory
medicine
Humans
Hemostatic Techniques/adverse effects
Coagulants
Hemostatic Techniques
business.industry
medicine.disease
Surgery
Dinoprostone/analogs & derivatives/therapeutic use
Relative risk
treatment outcome
business
Zdroj: Journal of Thrombosis and Haemostasis, Vol. 13, No 4 (2015) pp. 520-529
Journal of Thrombosis and Haemostasis
Journal of Thrombosis and Haemostasis, Wiley, 2015, 13 (4), pp.520-529. ⟨10.1111/jth.12844⟩
ISSN: 1538-7836
1538-7933
DOI: 10.1111/jth.12844⟩
Popis: SummaryBackground Case reports on recombinant human factor VIIa (rhuFVIIa) use in women with severe postpartum hemorrhage (PPH) showed encouraging results, but no randomized controlled trial (RCT) is available. Patients and methods Eighty-four women with severe PPH unresponsive to uterotonics were randomized to receive one early single rhuFVIIa infusion (n = 42) or standard care (no rhuFVIIa; n = 42). The primary efficacy outcome measure was the reduction of the need for specific second-line therapies, such as interventional hemostatic procedures, for blood loss and transfusions. The primary safety outcome measure was the number of deaths and thrombotic events during the 5 days following rhuFVIIa infusion. Results rhuFVIIa was associated with a reduction in the number of patients who needed second-line therapies compared with controls (standard care). Specifically, 39/42 (93%) patients in the standard care arm received second-line therapies and 22/42 (52%) patients in the rhuFVIIa arm (absolute difference, 41%; range, 18–63%; relative risk RR, 0.56 [0.42–0.76]). The delivery mode (vaginal or Cesarean section) did not affect the primary outcome. No death occurred. Two venous thrombotic events were recorded in the rhuFVIIa arm: one ovarian vein thrombosis and one deep vein thrombosis with a non-severe pulmonary embolism. Conclusion This open RCT in women with severe PPH refractory to uterotonics shows that rhuFVIIa reduces the need for specific second-line therapies in about one in three patients, with the occurrence of non-fatal venous thrombotic events in one in 20 patients.
Databáze: OpenAIRE
Externí odkaz: