The rFVIIa (Novoseven) has been tested in traumatic hemorrhage but its efficiency has not been proven yet in this context. A national register has been set up in France identifying the patients which received rFVIIa. Those patients had persistent and active bleeding after severe trauma despite surgery and/or interventional radiology embolization. The aim of this present study is to report the first clinical results in those situations of patients treated with rFVIIa.
It consists of a study of a prospective cohort in 36 centers, for 3 years, from April 1st 2008. The data of all patients who received rFVIIa in traumatic situation were collected. The investigators colligated clinical and biological parameters; have been analyzed treatment received during initial care, in intensive care before and after they received rFVIIa, length of stay in ICU, secondary effects, complications and patients outcome. ISS and TRISS score were calculated to predict mortality.
Study Type
OBSERVATIONAL
Enrollment
114
data collected by investigators
MEROUANI
Alençon, France
use of rFVIIa in haemorrhagic trauma compared to guidelines
Deviations with European guidelines use of rFVIIa
Time frame: twenty four hours
medico economic evaluation
number of patients receiving rFVIIa by year and posology by patient
Time frame: one year
security and efficiency use of rFVVa
Mandatory treatments after first dose administration of rFVIIa. Patients with serious adverse events (type) and incidence
Time frame: thirty days
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