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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 7 April 2015
Main ID:  NCT01103999
Date of registration: 12/04/2010
Prospective Registration: Yes
Primary sponsor: Centre Hospitalier Universitaire de Nimes
Public title: Prospective Evaluation of Spleen Injury Treatments in Languedoc Roussillon
Scientific title: Prospective Evaluation of Spleen Injury Treatments in Languedoc Roussilon, France
Date of first enrolment: May 2010
Target sample size: 93
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01103999
Study type:  Observational
Study design:  Observational Model: Cohort, Time Perspective: Prospective  
Phase:  N/A
Countries of recruitment
France
Contacts
Name:     Marie-Christine Le Moine, MD
Address: 
Telephone:
Email:
Affiliation:  Centre Hospitalier Universitaire de NĂ®mes
Key inclusion & exclusion 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



Age minimum: 16 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Trauma
Intervention(s)
Primary Outcome(s)
Number of deceased participants [Time Frame: 1 year]
Secondary Outcome(s)
Direct costs (euros per patient) [Time Frame: 1 year of follow up]
Days in hospital [Time Frame: 1 year of follow up]
Number of participants with certain morbidities [Time Frame: 3 months of follow up]
Secondary ID(s)
2009-A00969-48
AOI/2009/MCL-01
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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