National Registry of rFVIIa (Novoseven) in Haemorrhagic Traumatology (NOVO7)
|ClinicalTrials.gov Identifier: NCT01532661|
Recruitment Status : Completed
First Posted : February 14, 2012
Last Update Posted : November 18, 2014
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.
|Condition or disease||Intervention/treatment|
|Hemorrhage Bleeding||Other: observational study|
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|
|Actual Enrollment :||114 participants|
|Official Title:||National Registry of rFVIIa (Novoseven) in Haemorrhagic Traumatology|
|Study Start Date :||April 2008|
|Primary Completion Date :||September 2012|
|Study Completion Date :||December 2012|
haemorrhagic trauma received rFVIIa
Other: observational study
data collected by investigators
- use of rFVIIa in haemorrhagic trauma compared to guidelines [ Time Frame: twenty four hours ]Deviations with European guidelines use of rFVIIa
- medico economic evaluation [ Time Frame: one year ]number of patients receiving rFVIIa by year and posology by patient
- security and efficiency use of rFVVa [ Time Frame: thirty days ]Mandatory treatments after first dose administration of rFVIIa. Patients with serious adverse events (type) and incidence
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01532661
|Bourg En Bresse, France|
|Clermont Ferrand, France|
|Le Kremlin Bicetre, France|
|Mateo A Loris|
|Pierre Benite, France|
|Saint Etienne, France|
|Villefranche Sur Saone, France|
|Principal Investigator:||PAYEN JF, MD||University Hospital, Grenoble|