National Registry of rFVIIa (Novoseven) in Haemorrhagic Traumatology
NCT ID: NCT01532661
Last Updated: 2014-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
114 participants
OBSERVATIONAL
2008-04-30
2012-12-31
Brief Summary
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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
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ISS and TRISS score were calculated to predict mortality.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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observational study
haemorrhagic trauma received rFVIIa
observational study
data collected by investigators
Interventions
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observational study
data collected by investigators
Eligibility Criteria
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Inclusion Criteria
* patients admitted in ISU for haemorrhagic trauma
* patients received rFVIIa after the other treatment for bleeding control
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Société Française d'Anesthésie et de Réanimation
OTHER
University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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PAYEN JF, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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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
Countries
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References
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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.
Other Identifiers
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DCIC 07 20
Identifier Type: -
Identifier Source: org_study_id