Prospective Evaluation of Spleen Injury Treatments in Languedoc Roussillon

Completed

• Conditions: Trauma

• Registration Number: NCT01103999
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-12
• Study First Submitted QC: 2010-04-14
• Study First Posted: 2010-04-15
• Study Start: 2010-05
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of deceased participants	1 year	Mortality

Secondary Outcome Measures

Name	Time	Method
Number of participants with certain morbidities	3 months of follow up	The occurrence of pulmonary, thrombo-embolic, hemorrhagic, pancreatic, splenic and infectious morbidities are recorded.
Days in hospital	1 year of follow up
Direct costs (euros per patient)	1 year of follow up	Costs are calculated as a function of hospitalisation, surgical procedures, interventional radiology.

Trial Locations

Locations (12)

CH d'Avignon - Centre Hospitalier Henri Duffaut; 🇫🇷 Avignon, France

Centre Hospitalier Universitaire de Nîmes; 🇫🇷 Nîmes, France

Centre Hospitalier Antoine Gayraud; 🇫🇷 Carcassonne Cedex 9, France

Centre Hospitalier de Mende; 🇫🇷 Mende, France

Hôpital Saint Eloi; 🇫🇷 Montpellier, France

Centre Hospitalier Saint Jean; 🇫🇷 Perpignan, France

Centre Hospitalier d'Alès; 🇫🇷 Alès, France

Centre Hospitalier Général Louis Pasteur; 🇫🇷 Bagnols sur Ceze, France

Centre Hospitalier de Narbonne; 🇫🇷 Narbonne, France

Centre Hospitalier Général; 🇫🇷 Beziers, France

APHM - Hôpital Nord; 🇫🇷 Marseille Cedex 20, France

Centre Hospitalier du bassin de Thau; 🇫🇷 Sete, France