Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-27 @ 10:11 PM
Study NCT ID:
NCT01532661
Status:
COMPLETED
Last Update Posted:
2014-11-18
First Post:
2011-12-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
National Registry of rFVIIa (Novoseven) in Haemorrhagic Traumatology
Sponsor:
University Hospital, Grenoble
Organization:
Study Overview
Official Title:
National Registry of rFVIIa (Novoseven) in Haemorrhagic Traumatology
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NOVO7
Brief Summary:
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.
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.
Detailed 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.
ISS and TRISS score were calculated to predict mortality.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: