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

This study has been completed.
Sponsor:
Collaborators:
Novo Nordisk A/S
Société Française d'Anesthésie et de Réanimation
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01532661
First received: December 12, 2011
Last updated: November 17, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
Hemorrhage
Bleeding
Other: observational study

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: National Registry of rFVIIa (Novoseven) in Haemorrhagic Traumatology

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • use of rFVIIa in haemorrhagic trauma compared to guidelines [ Time Frame: twenty four hours ] [ Designated as safety issue: Yes ]
    Deviations with European guidelines use of rFVIIa


Secondary Outcome Measures:
  • medico economic evaluation [ Time Frame: one year ] [ Designated as safety issue: No ]
    number of patients receiving rFVIIa by year and posology by patient

  • security and efficiency use of rFVVa [ Time Frame: thirty days ] [ Designated as safety issue: Yes ]
    Mandatory treatments after first dose administration of rFVIIa. Patients with serious adverse events (type) and incidence


Enrollment: 114
Study Start Date: April 2008
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
observational study
haemorrhagic trauma received rFVIIa
Other: observational study
data collected by investigators

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532661

Locations
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, France
Sponsors and Collaborators
University Hospital, Grenoble
Novo Nordisk A/S
Société Française d'Anesthésie et de Réanimation
Investigators
Principal Investigator: PAYEN JF, MD University Hospital, Grenoble
  More Information

Publications:
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01532661     History of Changes
Other Study ID Numbers: DCIC 07 20
Study First Received: December 12, 2011
Last Updated: November 17, 2014
Health Authority: France: The Commission nationale de l’informatique et des libertés

Keywords provided by University Hospital, Grenoble:
TRAUMA
HAEMORRHAGIC
rVIIa
Complication of Trauma hemorrhage
bleeding
rFVIIa administration for hemorrhage after trauma

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014