Your browser doesn't support javascript.
loading
Post-authorization safety study of Clottafact® , a triply secured fibrinogen concentrate in congenital afibrinogenemia. A prospective observational study.
Négrier, C; Rothschild, C; Borg, J-Y; Lambert, T; Claeyssens, S; Sanhes, L; Stieltjes, N; Bertrand, A; André, M-H; Sié, P; Gruel, Y; Tellier, Z.
Afiliación
  • Négrier C; Edouard Herriot Hospital, Lyon, France.
  • Rothschild C; Hemophilia Centre, Necker Enfants Malades University Hospital - APHP Paris, Paris, France.
  • Borg JY; Charles Nicolle Hospital, Rouen, France.
  • Lambert T; Bicêtre Hospital, Kremlin Bicêtre, France.
  • Claeyssens S; Purpan Hospital, Toulouse, France.
  • Sanhes L; Saint-Jean Hospital, Perpignan, France.
  • Stieltjes N; Cochin Hospital, Paris, France.
  • Bertrand A; Medical Affairs, LFB Biomédicaments, Les Ulis, France.
  • André MH; Medical Affairs, LFB Biomédicaments, Les Ulis, France.
  • Sié P; Rangueil Hospital, Toulouse, France.
  • Gruel Y; Trousseau Hospital, Tours, France.
  • Tellier Z; Medical Affairs, LFB Biomédicaments, Les Ulis, France.
Vox Sang ; 111(4): 383-390, 2016 Nov.
Article en En | MEDLINE | ID: mdl-27583698
BACKGROUND AND OBJECTIVES: A new fibrinogen concentrate Clottafact® was developed according to European guidelines on plasma-derived products. A post-authorization safety study was set up in 2009 as part of the risk management plan. This was a non-interventional, prospective, non-comparative, multicenter study of the use of fibrinogen concentrate for congenital afibrinogenemia in real-life medical practice in France. MATERIALS AND METHODS: The analysis was descriptive and performed on 3 subgroups: prophylaxis vs. on-demand treatment, age (<6, <12 and ≥12) and severity of the deficiency. RESULTS: Fourteen patients [1-78 years] were included in 7 centres and followed for 1 year. Twenty-one adverse drug reactions (ADRs) classically reported with fibrinogen (pallor, chills, cough, vomiting, headache, urticaria and erythematous rash) were reported in 5 of 14 patients. Two ADRs were serious: an anaphylactic shock and a subclavian venous thrombosis with a favourable outcome without sequelae. In the nine patients under prophylaxis, 365 of 367 infusions were considered as successful (99·5%) and 2 as failures. For the five patients treated on-demand, the efficacy was rated as excellent for 27 of 48 infusions and good for the 21 others. CONCLUSION: This study confirms that the benefit/risk balance for this fibrinogen concentrate is favourable.
Asunto(s)
Palabras clave
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Fibrinógeno / Coagulantes / Afibrinogenemia Tipo de estudio: Clinical_trials / Etiology_studies / Guideline / Observational_studies / Risk_factors_studies Límite: Adolescent / Adult / Aged / Child / Child, preschool / Female / Humans / Infant / Male / Middle aged Idioma: En Revista: Vox Sang Año: 2016 Tipo del documento: Article País de afiliación: Francia Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Fibrinógeno / Coagulantes / Afibrinogenemia Tipo de estudio: Clinical_trials / Etiology_studies / Guideline / Observational_studies / Risk_factors_studies Límite: Adolescent / Adult / Aged / Child / Child, preschool / Female / Humans / Infant / Male / Middle aged Idioma: En Revista: Vox Sang Año: 2016 Tipo del documento: Article País de afiliación: Francia Pais de publicación: Reino Unido