Prospective Evaluation of Spleen Injury Treatments in Languedoc Roussillon

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01103999
First received: April 12, 2010
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

Descriptive, prospective, multicenter evaluation of spleen injury treatment in the Languedoc Roussilon region according to trauma severity, morbi-mortality and length of hospitalization.


Condition
Trauma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of Spleen Injury Treatments in Languedoc Roussilon, France

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Number of deceased participants [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Mortality


Secondary Outcome Measures:
  • Number of participants with certain morbidities [ Time Frame: 3 months of follow up ] [ Designated as safety issue: No ]
    The occurrence of pulmonary, thrombo-embolic, hemorrhagic, pancreatic, splenic and infectious morbidities are recorded.

  • Days in hospital [ Time Frame: 1 year of follow up ] [ Designated as safety issue: No ]
  • Direct costs (euros per patient) [ Time Frame: 1 year of follow up ] [ Designated as safety issue: No ]
    Costs are calculated as a function of hospitalisation, surgical procedures, interventional radiology.


Enrollment: 93
Study Start Date: May 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The population includes patients hospitalized for trauma to the spleen.

Criteria

Inclusion Criteria:

  • Hospitalized for abdominal trauma
  • diagnosis of splenic contusion confirmed by scanner or during surgery for hemodynamically unstable cases
  • patient has signed a consent form
  • patient is a beneficiary of or affiliated with a social security program

Exclusion Criteria:

  • Refuses to participate
  • Pregnant or breastfeeding
  • Patient under guardianship
  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: NCT01103999

Locations
France
Centre Hospitalier d'Alès
Alès, France, 30100
CH d'Avignon - Centre Hospitalier Henri Duffaut
Avignon, France, 84902
Centre Hospitalier Général Louis Pasteur
Bagnols sur Ceze, France, 30200
Centre Hospitalier Général
Beziers, France, 34525
Centre Hospitalier Antoine Gayraud
Carcassonne Cedex 9, France, 11890
APHM - Hôpital Nord
Marseille Cedex 20, France, 13915
Centre Hospitalier de Mende
Mende, France, 48001
Hôpital Saint Eloi
Montpellier, France, 34295
Centre Hospitalier de Narbonne
Narbonne, France, 11108
Centre Hospitalier Universitaire de Nîmes
Nîmes, France, 30029
Centre Hospitalier Saint Jean
Perpignan, France, 66000
Centre Hospitalier du bassin de Thau
Sete, France, 34200
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Marie-Christine Le Moine, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01103999     History of Changes
Other Study ID Numbers: AOI/2009/MCL-01, 2009-A00969-48
Study First Received: April 12, 2010
Last Updated: March 3, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
spleen

ClinicalTrials.gov processed this record on September 18, 2014