Rekombinantní aktivovaný faktor VII (rFVIIa) v lécbe závazného poporodního krvácení data z registru UniSeven v Ceské republice
[Recombinant activated factor VII in the treatment of life threatening post-partum haemorrhage; registry UniSeven in the Czech Republic]
Language Czech Country Czech Republic Media print
Document type Journal Article, Multicenter Study
PubMed
20925226
- MeSH
- Adult MeSH
- Factor VIIa adverse effects therapeutic use MeSH
- Hemorrhage drug therapy MeSH
- Humans MeSH
- Postpartum Hemorrhage therapy MeSH
- Registries MeSH
- Recombinant Proteins adverse effects therapeutic use MeSH
- Pregnancy MeSH
- Check Tag
- Adult MeSH
- Humans MeSH
- Male MeSH
- Pregnancy MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Geographicals
- Czech Republic MeSH
- Names of Substances
- Factor VIIa MeSH
- recombinant FVIIa MeSH Browser
- Recombinant Proteins MeSH
OBJECTIVE: To analyze the data related to the treatment of 80 Czech patients with life threatening postpartum haemorrhage recorded in the clinical registry UniSeven during years 2004-2009. DESIGN: Retrospective, observational, multicentre study. SETTINGS: ICU and Obstetrics departments of University and Regional hospitals in Czech Republic. MATERIAL AND METHODS: UniSeven is an international academic project of Masaryk University in Brno, Czech Republic, focused on recording of clinical data related to "off-label" use of rFVIIa (Novo Seven) in life threatening bleeding. Data of 80 case reports of post partum haemorrhage from the registry was analysed from the clinical (efficacy and safety) as well as laboratory aspects. RESULTS: In 97.5% of our patients the treatment with rFVIIa was able to control the bleeding. In 53 women (66.3%) only one dose of rFVIIa was sufficient to control the bleeding. The rest of the patient received two or more rFVIIa doses. First dose of rFVIIa given to patients who needed more than one dose was significantly lower (96.6 microg/kg) compared to patient succesfully treated with one dose only (110.6 microg/kg; p = 0.048). The mortality rate in our cohort of patients was 2.5%. We have not recorded any thrombembolic event as and adverse event related to the rFVIIa treatment. In 74.3% of patients where rFVIIa was administered before considering the hysterectomy, it was able to avoid hysterectomy what we consider to be a significant improvement of the patients' quality of life. CONCLUSIONS: Our data were also considered during the work up of national guidelines for the treatment of life threatening post-partum haemorrhage in the Czech Republic.