National Registry of rFVIIa (Novoseven) in Haemorrhagic Traumatology (NOVO7)
Recruitment status was Recruiting
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||National Registry of rFVIIa (Novoseven) in Haemorrhagic Traumatology|
- use of rFVIIa in haemorrhagic trauma compared to guidelines [ Time Frame: twenty four hours ] [ Designated as safety issue: Yes ]Deviations with European guidelines use of rFVIIa
- medico economic evaluation [ Time Frame: one year ] [ Designated as safety issue: No ]number of patients receiving rFVIIa by year and posology by patient
- security and efficiency use of rFVVa [ Time Frame: thirty days ] [ Designated as safety issue: Yes ]Mandatory treatments after first dose administration of rFVIIa. Patients with serious adverse events (type) and incidence
|Study Start Date:||May 2008|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
|haemorrhagic trauma received rFVIIa||
Other: observational study
data collected by investigators
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01532661
|Contact: ROLLAND Carole||CarRolland@chu-grenoble.fr|
|Bourg En Bresse, France|
|Clermont Ferrand, France|
|Le Kremlin Bicetre, France|
|Mateo A Loris||Recruiting|
|Pierre Benite, France|
|Saint Etienne, France|
|Villefranche Sur Saone, France|
|Principal Investigator:||PAYEN JF, MD||University Hospital, Grenoble|