Recombinant activated factor VIi in the treatment of life threatening post-partum haemorrhage; registry UniSeven in the Czech Republic
Seidlová, D.; Blatný, J.; Penka, M.; Ovesná, P.; Brabec, P.; Sevcík, P.; Ventruba, P.; Cerný, V.
Ceska Gynekologie 75(4): 297-305
2010
ISSN/ISBN: 1210-7832 PMID: 20925226 Document Number: 639004
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. Retrospective, observational, multicentre study. ICU and Obstetrics departments of University and Regional hospitals in Czech Republic. 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. 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. 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.