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NCT01103999 Clinical Trial

Prospective Evaluation of Spleen Injury Treatments in Languedoc Roussillon

Trauma Clinical Trial

Official title:
Prospective Evaluation of Spleen Injury Treatments in Languedoc Roussilon, France

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01103999
Other study ID # AOI/2009/MCL-01
Secondary ID 2009-A00969-48
Status Completed
Phase N/A
First received April 12, 2010
Last updated March 25, 2015
Start date May 2010
Est. completion date May 2012

Study information
Verified date March 2015
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 93
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
France Centre Hospitalier d'Alès Alès
France CH d'Avignon - Centre Hospitalier Henri Duffaut Avignon
France Centre Hospitalier Général Louis Pasteur Bagnols sur Ceze
France Centre Hospitalier Général Beziers
France Centre Hospitalier Antoine Gayraud Carcassonne Cedex 9
France APHM - Hôpital Nord Marseille Cedex 20
France Centre Hospitalier de Mende Mende
France Hôpital Saint Eloi Montpellier
France Centre Hospitalier de Narbonne Narbonne
France Centre Hospitalier Universitaire de Nîmes Nîmes
France Centre Hospitalier Saint Jean Perpignan
France Centre Hospitalier du bassin de Thau Sete

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of deceased participants Mortality 1 year No
Secondary Number of participants with certain morbidities The occurrence of pulmonary, thrombo-embolic, hemorrhagic, pancreatic, splenic and infectious morbidities are recorded. 3 months of follow up No
Secondary Days in hospital 1 year of follow up No
Secondary Direct costs (euros per patient) Costs are calculated as a function of hospitalisation, surgical procedures, interventional radiology. 1 year of follow up No
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