National Registry of rFVIIa (Novoseven) in Haemorrhagic Traumatology

Bleeding Clinical Trial

— NOVO7  

Official title:

National Registry of rFVIIa (Novoseven) in Haemorrhagic Traumatology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01532661
• Other study ID #: DCIC 07 20
• Status: Completed
• Phase: N/A
• First received: December 12, 2011
• Last updated: November 17, 2014
• Start date: April 2008
• Est. completion date: December 2012

Study information

• Verified date: November 2014
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage

Intervention

Other:
• observational study
data collected by investigators

Locations

Country	Name	City	State
France	MEROUANI	Alencon
France	LAIGLE	Amiens
France	SANTRE	Annecy
France	MOREL	Bordeaux
France	SEDILLOT	Bourg En Bresse
France	BULEON	Caen
France	MIQUET	Chambery
France	DEBIEN	Clamart
France	GUELON	Clermont Ferrand
France	PEASE	Clichy
France	COOK	Creteil
France	NADJI	Dijon
France	Vinsiniti	GAP
France	DECLETY	Grenoble
France	Duranteau	Le Kremlin Bicetre
France	GARRIGUE	Lille
France	FLOCARD	Lyon
France	GARCIN	Marseille
France	FAVIER	Metz
France	CHARBIT	Montpellier
France	YUNG	Montpellier
France	AUDIBERT	Nancy
France	CHUPIN	Nantes
France	ICHAI	Nice
France	LEFRANT	Nimes
France	JOURNOIS	Paris
France	LANGERON	Paris
France	Mateo A Loris	Paris
France	DAVID	Pierre Benite
France	Nanadoumgar	Poitiers
France	LEPOUSE	Reims
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

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Novo Nordisk A/S, Société Française d'Anesthésie et de Réanimation

Country where clinical trial is conducted

France, 

References & Publications (5)

Boffard KD, Riou B, Warren B, Choong PI, Rizoli S, Rossaint R, Axelsen M, Kluger Y; NovoSeven Trauma Study Group. Recombinant factor VIIa as adjunctive therapy for bleeding control in severely injured trauma patients: two parallel randomized, placebo-controlled, double-blind clinical trials. J Trauma. 2005 Jul;59(1):8-15; discussion 15-8. — View Citation

Delannoy B, Levrat A, Chamouard V, Aulagner G, Perdrix JP, Négrier C, Allaouchiche B. [Off label use of recombinant activated factor VII: a practice survey]. Ann Fr Anesth Reanim. 2007 Sep;26(9):774-9. Epub 2007 Jul 16. French. — View Citation

Harrison TD, Laskosky J, Jazaeri O, Pasquale MD, Cipolle M. "Low-dose" recombinant activated factor VII results in less blood and blood product use in traumatic hemorrhage. J Trauma. 2005 Jul;59(1):150-4. — View Citation

Martinowitz U, Kenet G, Segal E, Luboshitz J, Lubetsky A, Ingerslev J, Lynn M. Recombinant activated factor VII for adjunctive hemorrhage control in trauma. J Trauma. 2001 Sep;51(3):431-8; discussion 438-9. — View Citation

Rizoli SB, Boffard KD, Riou B, Warren B, Iau P, Kluger Y, Rossaint R, Tillinger M; NovoSeven Trauma Study Group. Recombinant activated factor VII as an adjunctive therapy for bleeding control in severe trauma patients with coagulopathy: subgroup analysis — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	use of rFVIIa in haemorrhagic trauma compared to guidelines	Deviations with European guidelines use of rFVIIa	twenty four hours	Yes
Secondary	medico economic evaluation	number of patients receiving rFVIIa by year and posology by patient	one year	No
Secondary	security and efficiency use of rFVVa	Mandatory treatments after first dose administration of rFVIIa. Patients with serious adverse events (type) and incidence	thirty days	Yes