Postauthorization safety study of Clottafact ® , a triply secured fibrinogen concentrate in acquired fibrinogen deficiency: a prospective observational study
| Autor: | Vincent Piriou, Annie Borel-Derlon, A. Bertrand, J. Picard, Pierre Sié, Thierry Lambert, Y. Ozier, S. Claeyssens, E. de Maistre, Y. Gruel, M.-H. André, N. Stieltjes, Z. Tellier, A. Ducloy-Bouthors, François Fourrier, Claude Negrier, S. Boileau, Pascal Colson |
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| Přispěvatelé: | Hôpital Edouard Herriot [CHU - HCL], Hospices Civils de Lyon (HCL), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), CHU Dijon, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), AP-HP - Hôpital Cochin Broca Hôtel Dieu [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Institut de Génomique Fonctionnelle (IGF), Université de Montpellier (UM)-Université Montpellier 1 (UM1)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Montpellier 2 - Sciences et Techniques (UM2)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Universitaire [Grenoble] (CHU), AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), Hôpital Purpan [Toulouse], CHU Toulouse [Toulouse], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), LFB Biomédicaments, Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Hôpital de Rangueil, Hôpital Trousseau, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours) |
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Fibrinogen deficiency
medicine.medical_specialty 030204 cardiovascular system & hematology Fibrinogen 03 medical and health sciences 0302 clinical medicine Internal medicine medicine Drug reaction fibrinogen concentrate business.industry Medical practice postauthorization safety study 030208 emergency & critical care medicine [SDV.MHEP.HEM]Life Sciences [q-bio]/Human health and pathology/Hematology Hematology General Medicine Bleed medicine.disease 3. Good health Pulmonary embolism Safety profile acquired fibrinogen deficiency Observational study business non-interventional study medicine.drug |
| Zdroj: | Vox Sanguinis Vox Sanguinis, Wiley, 2018, 113 (2), pp.120-127. ⟨10.1111/vox.12624⟩ |
| ISSN: | 0042-9007 1423-0410 |
| Popis: | International audience; BACKGROUND AND OBJECTIVES:A postauthorization safety study was performed between 2009 and 2012 to describe the use of Clottafact® in acquired fibrinogen deficiency in real-life medical practice in France.MATERIALS AND METHODS:One hundred and fifty patients were planned for 28 days of prospective follow-up after infusion. The analysis of this observational study was descriptive and performed according to the type of treatment (curative or preventive) and the origin of the bleed.RESULTS:One hundred and fifty-six patients (16-87 years) were included in 13 centres and treated in five different medical bleeding situations: postpartum (59), other gynaecological/obstetrical (6), trauma (34), liver (13), cardiovascular (23) and other various bleeding situations (21). The mean follow-up time was 18·9 ± 12·3 days. Two patients presented adverse drug reactions: one a pulmonary embolism and the other a four-site venous thromboembolic episode. All were serious with a dubious causal relationship with the study treatment. Efficacy data were collected as a secondary objective. In 150 patients receiving curative treatment, 117 of 159 infusions (73·6%) were considered as successful by the investigators, 35 as moderate (22%) and seven as no response (4·4%).CONCLUSION:The Clottafact® safety profile observed during the study matched the known profile of fibrinogen during use. |
| Databáze: | OpenAIRE |
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