2016
DOI: 10.1111/vox.12424
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Post‐authorization safety study of Clottafact®, a triply secured fibrinogen concentrate in congenital afibrinogenemia. A prospective observational study

Abstract: This study confirms that the benefit/risk balance for this fibrinogen concentrate is favourable.

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Cited by 16 publications
(25 citation statements)
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“…Allergic or hypersensitivity reactions are a known risk of fibrinogen and other coagulation factor concentrates, with anaphylactic shock, urticaria, and rash all having been previously reported . In the present study, a single mild skin reaction was reported.…”
Section: Discussionsupporting
confidence: 63%
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“…Allergic or hypersensitivity reactions are a known risk of fibrinogen and other coagulation factor concentrates, with anaphylactic shock, urticaria, and rash all having been previously reported . In the present study, a single mild skin reaction was reported.…”
Section: Discussionsupporting
confidence: 63%
“…A retrospective analysis of 12 patients with congenital fibrinogen deficiency treated with Haemocomplettan ® P rated hemostatic efficacy as very good (the highest rating) for all 26 BEs; however, these data were based on a subjective scoring system without independent adjudication . In a postauthorization study of Clottafact ® , five patients with afibrinogenemia received 48 infusions for treatment of 49 hemorrhagic events, with efficacy rated as excellent for 27 and good for 21 infusions, giving a success rate (rating of excellent/good) of 100% using an objective 4‐point scale …”
Section: Discussionmentioning
confidence: 99%
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“…26 Supplementary fibrinogen infusions are required in the postsurgical period to target fibrinogen levels at least >1 g L −1 until haemostasis is achieved and above 0.5 g L −1 until wound healing is complete. 25 The mean doses for prophylaxis ranged from 20 to 80 mg kg −1 in the youngest patients, reflecting the possibility of PK variability across age sub-groups as described for other fibrinogen concentrates. 25 The mean doses for prophylaxis ranged from 20 to 80 mg kg −1 in the youngest patients, reflecting the possibility of PK variability across age sub-groups as described for other fibrinogen concentrates.…”
Section: Effi C Ac Ymentioning
confidence: 98%
“…In the study of Manco-Johnson et al, 17 two patients experienced four mild adverse events between 72 hours and 9 days after Haemocomplettan P ® infusion. 25 Among the 16 adverse events following Fibryga ® infusions reported in the interim FORMA-02, only a mild skin reaction was deemed possibly related to the infusion. 25 Among the 16 adverse events following Fibryga ® infusions reported in the interim FORMA-02, only a mild skin reaction was deemed possibly related to the infusion.…”
Section: Safe T Ymentioning
confidence: 99%