Clinical trial NCT01532661: National Registry of rFVIIa (Novoseven) in Haemorrhagic Traumatology
Official title: National Registry of rFVIIa (Novoseven) in Haemorrhagic Traumatology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhage
Bleeding
Keywords: TRAUMA
HAEMORRHAGIC
rVIIa
Complication of Trauma hemorrhage
bleeding
rFVIIa administration for hemorrhage after trauma
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
name: Société Française d'Anesthésie et de Réanimation
First posted: 2012-02-14
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients admitted in ICU after massive bleeding trauma and received rFVIIa

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.

Eligibility criteria: 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

Primary outcomes:
measure: use of rFVIIa in haemorrhagic trauma compared to guidelines
timeFrame: twenty four hours
Secondary outcomes:
measure: medico economic evaluation
timeFrame: one year
measure: security and efficiency use of rFVVa
timeFrame: thirty days
Other outcomes:
Locations:
city: Alencon
country: France
facility: MEROUANI
city: Amiens
country: France
facility: LAIGLE
city: Annecy
country: France
facility: SANTRE
city: Bordeaux
country: France
facility: MOREL
city: Bourg En Bresse
country: France
facility: SEDILLOT
city: Caen
country: France
facility: BULEON
city: Chambery
country: France
facility: MIQUET
city: Clamart
country: France
facility: DEBIEN
city: Clermont Ferrand
country: France
facility: GUELON
city: Clichy
country: France
facility: PEASE
city: Creteil
country: France
facility: COOK
city: Dijon
country: France
facility: NADJI
city: GAP
country: France
facility: Vinsiniti
city: Grenoble
country: France
facility: DECLETY
city: Le Kremlin Bicetre
country: France
facility: Duranteau
city: Lille
country: France
facility: GARRIGUE
city: Lyon
country: France
facility: FLOCARD
city: Marseille
country: France
facility: GARCIN
city: Metz
country: France
facility: FAVIER
city: Montpellier
country: France
facility: CHARBIT
city: Montpellier
country: France
facility: YUNG
city: Nancy
country: France
facility: AUDIBERT
city: Nantes
country: France
facility: CHUPIN
city: Nice
country: France
facility: ICHAI
city: Nimes
country: France
facility: LEFRANT
city: Paris
country: France
facility: JOURNOIS
city: Paris
country: France
facility: LANGERON
city: Paris
country: France
facility: Mateo A Loris
city: Pierre Benite
country: France
facility: DAVID
city: Poitiers
country: France
facility: Nanadoumgar
city: Reims
country: France
facility: LEPOUSE
city: Rennes
country: France
facility: Bleichner
city: Rouen
country: France
facility: GUITARD
city: Saint Etienne
country: France
facility: MARTIN
city: Strasbourg
country: France
facility: FREYS
city: Toulon
country: France
facility: MEAUDRE
city: Toulouse
country: France
facility: OLIVIER
city: Vannes
country: France
facility: LEBAS
city: Villefranche Sur Saone
country: France
facility: JAULT
Study officials:
affiliation: University Hospital, Grenoble
name: PAYEN JF, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1097/01.ta.0000171453.37949.b7.
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. doi: 10.1097/00005373-200109000-00002.
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 from two randomized trials. Crit Care. 2006;10(6):R178. doi: 10.1186/cc5133.
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. doi: 10.1097/01.ta.0000171470.39742.8e.
citation: Delannoy B, Levrat A, Chamouard V, Aulagner G, Perdrix JP, Negrier C, Allaouchiche B. [Off label use of recombinant activated factor VII: a practice survey]. Ann Fr Anesth Reanim. 2007 Sep;26(9):774-9. doi: 10.1016/j.annfar.2007.06.001. Epub 2007 Jul 16. French.