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Prospective Evaluation of Spleen Injury Treatments in Languedoc Roussillon

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ClinicalTrials.gov Identifier: NCT01103999
Recruitment Status : Completed
First Posted : April 15, 2010
Last Update Posted : March 26, 2015
Information provided by (Responsible Party):

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

Condition or disease

Study Design

Study Type : Observational
Actual Enrollment : 93 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of Spleen Injury Treatments in Languedoc Roussilon, France
Study Start Date : May 2010
Primary Completion Date : May 2012
Study Completion Date : May 2012
Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Number of deceased participants [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Number of participants with certain morbidities [ Time Frame: 3 months of follow up ]
    The occurrence of pulmonary, thrombo-embolic, hemorrhagic, pancreatic, splenic and infectious morbidities are recorded.

  2. Days in hospital [ Time Frame: 1 year of follow up ]
  3. Direct costs (euros per patient) [ Time Frame: 1 year of follow up ]
    Costs are calculated as a function of hospitalisation, surgical procedures, interventional radiology.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The population includes patients hospitalized for trauma to the spleen.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01103999

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
Principal Investigator: Marie-Christine Le Moine, MD Centre Hospitalier Universitaire de Nîmes
More Information

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 ( Other Identifier: Afssaps, RCB number )
First Posted: April 15, 2010    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015

Keywords provided by Centre Hospitalier Universitaire de Nīmes: