National Registry of rFVIIa (Novoseven) in Haemorrhagic Traumatology

Completed

• Conditions: Hemorrhage; Bleeding
• Interventions: Other: observational study

• Registration Number: NCT01532661
• Lead Sponsor: University Hospital, Grenoble

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.

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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2011-12-12
• Study First Submitted QC: 2012-02-09
• Study First Posted: 2012-02-14
• Primary Completion: 2012-09
• Study Completion: 2012-12
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
observational study	observational study	haemorrhagic trauma received rFVIIa

Primary Outcome Measures

Name	Time	Method
use of rFVIIa in haemorrhagic trauma compared to guidelines	twenty four hours	Deviations with European guidelines use of rFVIIa

Secondary Outcome Measures

Name	Time	Method
security and efficiency use of rFVVa	thirty days	Mandatory treatments after first dose administration of rFVIIa. Patients with serious adverse events (type) and incidence
medico economic evaluation	one year	number of patients receiving rFVIIa by year and posology by patient

Trial Locations

Locations (39)

LAIGLE; 🇫🇷 Amiens, France

Vinsiniti; 🇫🇷 GAP, France

GARRIGUE; 🇫🇷 Lille, France

FLOCARD; 🇫🇷 Lyon, France

FAVIER; 🇫🇷 Metz, France

GARCIN; 🇫🇷 Marseille, France

YUNG; 🇫🇷 Montpellier, France

AUDIBERT; 🇫🇷 Nancy, France

CHUPIN; 🇫🇷 Nantes, France

ICHAI; 🇫🇷 Nice, France

LEFRANT; 🇫🇷 Nimes, France

JOURNOIS; 🇫🇷 Paris, France

LANGERON; 🇫🇷 Paris, France

DAVID; 🇫🇷 Pierre Benite, France

Mateo A Loris; 🇫🇷 Paris, France

Bleichner; 🇫🇷 Rennes, France

GUITARD; 🇫🇷 Rouen, France

MARTIN; 🇫🇷 Saint Etienne, France

FREYS; 🇫🇷 Strasbourg, France

MEAUDRE; 🇫🇷 Toulon, France

OLIVIER; 🇫🇷 Toulouse, France

LEBAS; 🇫🇷 Vannes, France

JAULT; 🇫🇷 Villefranche Sur Saone, France

LEPOUSE; 🇫🇷 Reims, France

MEROUANI; 🇫🇷 Alencon, France

MOREL; 🇫🇷 Bordeaux, France

GUELON; 🇫🇷 Clermont Ferrand, France

COOK; 🇫🇷 Creteil, France

SEDILLOT; 🇫🇷 Bourg En Bresse, France

DEBIEN; 🇫🇷 Clamart, France

CHARBIT; 🇫🇷 Montpellier, France

BULEON; 🇫🇷 Caen, France

PEASE; 🇫🇷 Clichy, France

DECLETY; 🇫🇷 Grenoble, France

Duranteau; 🇫🇷 Le Kremlin Bicetre, France

SANTRE; 🇫🇷 Annecy, France

Nanadoumgar; 🇫🇷 Poitiers, France

MIQUET; 🇫🇷 Chambery, France

NADJI; 🇫🇷 Dijon, France