TraumaNCT01103999
Prospective Evaluation of Spleen Injury Treatments in Languedoc Roussillon
An observational study of Trauma, run by Centre Hospitalier Universitaire de Nīmes at 12 sites in France.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Trauma
- How many people
- 93 participants
- Where
- 12 sitesFrance
- Study dates
- May 2010to 31 May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The population includes patients hospitalized for trauma to the spleen.
Who may be able to join
- 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
Who cannot join
- Refuses to participate
- Pregnant or breastfeeding
- Patient under guardianship
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Centre Hospitalier d'Alès
Alès, 30100
CH d'Avignon - Centre Hospitalier Henri Duffaut
Avignon, 84902
Centre Hospitalier Général Louis Pasteur
Bagnols-sur-Cèze, 30200
Centre Hospitalier Général
Béziers, 34525
Centre Hospitalier Antoine Gayraud
Carcassonne, 11890
APHM - Hôpital Nord
Marseille, 13915
Centre Hospitalier de Mende
Mende, 48001
Hôpital Saint Eloi
Montpellier, 34295
Centre Hospitalier de Narbonne
Narbonne, 11108
Centre Hospitalier Universitaire de Nîmes
Nîmes, 30029
Centre Hospitalier Saint Jean
Perpignan, 66000
Centre Hospitalier du bassin de Thau
Sète, 34200
About this study
Official title: Prospective Evaluation of Spleen Injury Treatments in Languedoc Roussilon, France
Descriptive, prospective, multicenter evaluation of spleen injury treatment in the Languedoc Roussilon region according to trauma severity, morbi-mortality and length of hospitalization.
- Conditions
- Trauma
- Keywords
- spleen
- Medical subject headings
- Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of deceased participants
Mortality
Measured: 1 year
Secondary outcomes (3)
Number of participants with certain morbidities
The occurrence of pulmonary, thrombo-embolic, hemorrhagic, pancreatic, splenic and infectious morbidities are recorded.
Measured: 3 months of follow up
Days in hospital
Measured: 1 year of follow up
Direct costs (euros per patient)
Costs are calculated as a function of hospitalisation, surgical procedures, interventional radiology.
Measured: 1 year of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startMay 2010
- Primary completion31 May 2013
- Study completion31 May 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Christine Le Moine, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103999
- Sponsor's protocol ID
- AOI/2009/MCL-01
- Other IDs
- 2009-A00969-48
- Status last verified
- Mar 2015
- First submitted
- 12 Apr 2010
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Chastang L, Bege T, Prudhomme M, Simonnet AC, Herrero A, Guillon F, Bono D, Nini E, Buisson T, Carbonnel G, Passebois L, Vacher C, Le Moine MC. Is non-operative management of severe blunt splenic injury safer than embolization or surgery? Results from a French prospective multicenter study. J Visc Surg. 2015 Apr;152(2):85-91. doi: 10.1016/j.jviscsurg.2015.01.003. Epub 2015 Feb 3.
PubMed 25662597
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Spleen Injury Treatments in Languedoc Roussilon, France
- ClinicalTrials.gov ID
- NCT01103999
- Acronym / sponsor ID
- AOI/2009/MCL-01
- Conditions
- Trauma
- Keywords
- spleen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- 31 May 2013 (actual)
- Study completion
- 31 May 2013 (actual)
- First posted
- 15 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Descriptive, prospective, multicenter evaluation of spleen injury treatment in the Languedoc Roussilon region according to trauma severity, morbi-mortality and length of hospitalization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population includes patients hospitalized for trauma to the spleen.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Refuses to participate
- Pregnant or breastfeeding
- Patient under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of deceased participants
Time frame: 1 year
Mortality
3 secondary outcomes
Number of participants with certain morbidities
Time frame: 3 months of follow up
Days in hospital
Time frame: 1 year of follow up
Direct costs (euros per patient)
Time frame: 1 year of follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Results publication: PubMed 25662597Chastang L, Bege T, Prudhomme M, Simonnet AC, Herrero A, Guillon F, Bono D, Nini E, Buisson T, Carbonnel G, Passebois L, Vacher C, Le Moine MC. Is non-operative management of severe blunt splenic injury safer than embolization or surgery? Results from a French prospective multicenter study. J Visc Surg. 2015 Apr;152(2):85-91. doi: 10.1016/j.jviscsurg.2015.01.003. Epub 2015 Feb 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Christine Le Moine, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma, run by Centre Hospitalier Universitaire de Nīmes at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of deceased participants (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01103999, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.