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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by University Hospital, Grenoble
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: October 8, 2012
Last verified: October 2012
  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


Estimated Enrollment: 200
Study Start Date: May 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Contacts
Contact: ROLLAND Carole CarRolland@chu-grenoble.fr

Locations
France
MEROUANI Recruiting
Alencon, France
LAIGLE Recruiting
Amiens, France
SANTRE Recruiting
Annecy, France
MOREL Recruiting
Bordeaux, France
SEDILLOT Recruiting
Bourg En Bresse, France
BULEON Recruiting
Caen, France
MIQUET Recruiting
Chambery, France
DEBIEN Recruiting
Clamart, France
GUELON Recruiting
Clermont Ferrand, France
PEASE Recruiting
Clichy, France
COOK Recruiting
Creteil, France
NADJI Recruiting
Dijon, France
Vinsiniti Recruiting
GAP, France
DECLETY Recruiting
Grenoble, France
Duranteau Recruiting
Le Kremlin Bicetre, France
GARRIGUE Recruiting
Lille, France
FLOCARD Recruiting
Lyon, France
GARCIN Recruiting
Marseille, France
FAVIER Recruiting
Metz, France
CHARBIT Recruiting
Montpellier, France
YUNG Recruiting
Montpellier, France
AUDIBERT Recruiting
Nancy, France
CHUPIN Recruiting
Nantes, France
ICHAI Recruiting
Nice, France
LEFRANT Recruiting
Nimes, France
JOURNOIS Recruiting
Paris, France
LANGERON Recruiting
Paris, France
Mateo A Loris Recruiting
Paris, France
DAVID Recruiting
Pierre Benite, France
Nanadoumgar Recruiting
Poitiers, France
LEPOUSE Recruiting
Reims, France
Bleichner Recruiting
Rennes, France
GUITARD Recruiting
Rouen, France
MARTIN Recruiting
Saint Etienne, France
FREYS Recruiting
Strasbourg, France
MEAUDRE Recruiting
Toulon, France
OLIVIER Recruiting
Toulouse, France
LEBAS Recruiting
Vannes, France
JAULT Recruiting
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: October 8, 2012
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 September 30, 2014