Post-authorization safety study of Clottafact® , a triply secured fibrinogen concentrate in congenital afibrinogenemia. A prospective observational study.
Vox Sang
; 111(4): 383-390, 2016 Nov.
Article
em En
| MEDLINE
| ID: mdl-27583698
ABSTRACT
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 ANDMETHODS:
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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Fibrinogênio
/
Coagulantes
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Afibrinogenemia
Tipo de estudo:
Clinical_trials
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Etiology_studies
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Guideline
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Observational_studies
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Risk_factors_studies
Limite:
Adolescent
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Adult
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Aged
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Child
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Child, preschool
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Female
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Humans
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Infant
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Male
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Middle aged
Idioma:
En
Revista:
Vox Sang
Ano de publicação:
2016
Tipo de documento:
Article
País de afiliação:
França