An observational study in Hemorrhage and Bleeding, sponsored by University Hospital, Grenoble. Completed at 39 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-11-18.
Sponsored by University Hospital, Grenoble · Observational
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.
3,011 studies on the registry are indexed under Hemorrhage; 466 are open to participants now.
This study's enrollment of 114 is below the median of 150 across 897 observational studies indexed under Hemorrhage.
Browse Hemorrhage studies →University Hospital, Grenoble is the lead sponsor of 835 studies on the registry; 207 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients admitted in ICU after massive bleeding trauma and received rFVIIa
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
haemorrhagic trauma received rFVIIa
Other: observational study
data collected by investigators
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
The record gives a start of Apr 2008, a primary completion of Sep 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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