National Registry of rFVIIa (Novoseven) in Haemorrhagic Traumatology (NOVO7)

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.

Study Overview

• Status: Completed
• Conditions: Hemorrhage; Bleeding
• Intervention / Treatment: Other: observational study

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 Type: Observational
• Enrollment (Actual): 114

Contacts and Locations

Study Locations

• France
  • Alencon, France
    • MEROUANI
  • Amiens, France
    • LAIGLE
  • Annecy, France
    • SANTRE
  • Bordeaux, France
    • Morel
  • Bourg En Bresse, France
    • SEDILLOT
  • Caen, France
    • BULEON
  • Chambery, France
    • MIQUET
  • Clamart, France
    • DEBIEN
  • Clermont Ferrand, France
    • GUELON
  • Clichy, France
    • PEASE
  • Creteil, France
    • COOK
  • Dijon, France
    • NADJI
  • GAP, France
    • Vinsiniti
  • Grenoble, France
    • DECLETY
  • Le Kremlin Bicetre, France
    • Duranteau
  • Lille, France
    • GARRIGUE
  • Lyon, France
    • FLOCARD
  • Marseille, France
    • GARCIN
  • Metz, France
    • FAVIER
  • Montpellier, France
    • CHARBIT
  • Montpellier, France
    • YUNG
  • Nancy, France
    • AUDIBERT
  • Nantes, France
    • CHUPIN
  • Nice, France
    • ICHAI
  • Nimes, France
    • LEFRANT
  • Paris, France
    • JOURNOIS
  • Paris, France
    • LANGERON
  • Paris, France
    • Mateo A Loris
  • Pierre Benite, France
    • DAVID
  • Poitiers, France
    • Nanadoumgar
  • Reims, France
    • LEPOUSE
  • Rennes, France
    • Bleichner
  • Rouen, France
    • GUITARD
  • Saint Etienne, France
    • MARTIN
  • Strasbourg, France
    • FREYS
  • Toulon, France
    • MEAUDRE
  • Toulouse, France
    • OLIVIER
  • Vannes, France
    • LEBAS
  • Villefranche Sur Saone, France
    • JAULT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients admitted in ICU after massive bleeding trauma and received rFVIIa

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
observational study; haemorrhagic trauma received rFVIIa	Other: observational study; data collected by investigators

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
use of rFVIIa in haemorrhagic trauma compared to guidelines	Deviations with European guidelines use of rFVIIa	twenty four hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Novo Nordisk A/S; Société Française d'Anesthésie et de Réanimation
• Investigators: Principal Investigator: PAYEN JF, MD, University Hospital, Grenoble

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: December 12, 2011
• First Submitted That Met QC Criteria: February 9, 2012
• First Posted (Estimate): February 14, 2012

Study Record Updates

• Last Update Posted (Estimate): November 18, 2014
• Last Update Submitted That Met QC Criteria: November 17, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: bleeding; rVIIa; TRAUMA; HAEMORRHAGIC; Complication of Trauma hemorrhage; rFVIIa administration for hemorrhage after trauma
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: DCIC 07 20