National Registry of rFVIIa (Novoseven) in Haemorrhagic Traumatology
NOVO7
1 other identifier
observational
114
1 country
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2008
Longer than P75 for all trials
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 12, 2011
CompletedFirst Posted
Study publicly available on registry
February 14, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedNovember 18, 2014
November 1, 2014
4.4 years
December 12, 2011
November 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
use of rFVIIa in haemorrhagic trauma compared to guidelines
Deviations with European guidelines use of rFVIIa
twenty four hours
Secondary Outcomes (2)
medico economic evaluation
one year
security and efficiency use of rFVVa
thirty days
Study Arms (1)
observational study
haemorrhagic trauma received rFVIIa
Interventions
Eligibility Criteria
All patients admitted in ICU after massive bleeding trauma and received rFVIIa
You may qualify if:
- people affiliated to social security
- patients admitted in ISU for haemorrhagic trauma
- patients received rFVIIa after the other treatment for bleeding control
You may not qualify if:
- allergy or hypersensitivity to rVIIa or one of its component
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Grenoblelead
- Novo Nordisk A/Scollaborator
- Société Française d'Anesthésie et de Réanimationcollaborator
Study Sites (39)
MEROUANI
Alençon, France
LAIGLE
Amiens, France
SANTRE
Annecy, France
MOREL
Bordeaux, France
SEDILLOT
Bourg-en-Bresse, France
BULEON
Caen, France
MIQUET
Chambéry, France
DEBIEN
Clamart, France
GUELON
Clermont-Ferrand, France
PEASE
Clichy, France
COOK
Créteil, France
NADJI
Dijon, France
Vinsiniti
Gap, France
DECLETY
Grenoble, France
Duranteau
Le Kremlin-Bicêtre, 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
Nîmes, France
JOURNOIS
Paris, France
LANGERON
Paris, France
Mateo A Loris
Paris, France
DAVID
Pierre-Bénite, 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-Saône, France
Related 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. doi: 10.1097/01.ta.0000171453.37949.b7.
PMID: 16096533BACKGROUNDMartinowitz 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.
PMID: 11535886RESULTRizoli 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.
PMID: 17184516RESULTHarrison 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.
PMID: 16096555RESULTDelannoy 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.
PMID: 17629661RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
PAYEN JF, MD
University Hospital, Grenoble
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2011
First Posted
February 14, 2012
Study Start
April 1, 2008
Primary Completion
September 1, 2012
Study Completion
December 1, 2012
Last Updated
November 18, 2014
Record last verified: 2014-11