| Autor: |
C, Négrier, A-S, Ducloy-Bouthors, V, Piriou, E, De Maistre, N, Stieltjes, A, Borel-Derlon, P, Colson, J, Picard, T, Lambert, S, Claeyssens, S, Boileau, A, Bertrand, M-H, André, F, Fourrier, Y, Ozier, P, Sié, Y, Gruel, Z, Tellier |
| Rok vydání: |
2017 |
| Předmět: |
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| Zdroj: |
Vox sanguinis. 113(2) |
| ISSN: |
1423-0410 |
| Popis: |
A postauthorization safety study was performed between 2009 and 2012 to describe the use of ClottafactOne 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.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%).The Clottafact |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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