National Registry of rFVIIa (Novoseven) in Haemorrhagic Traumatology (NOVO7)
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About
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.
Full description
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.
Enrollment
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Volunteers
Inclusion criteria
- people affiliated to social security
- patients admitted in ISU for haemorrhagic trauma
- patients received rFVIIa after the other treatment for bleeding control
Exclusion criteria
- allergy or hypersensitivity to rVIIa or one of its component
Trial design
114 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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