Severe Trauma (With or Without Traumatic Brain Injury)NCT02426255
Post Traumatic Critical Complications: a Prospective Cohort Study (ATLANREA)
An observational study of Severe Trauma (With or Without Traumatic Brain Injury), run by Nantes University Hospital at 5 sites in France.
Trial summary
The purpose of this observational epidemiological study is to investigate the management and the complications associated with severe trauma. Data will be analysed to answer pre-defined scientific projects and to improve management of these conditions. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Severe Trauma (With or Without Traumatic Brain Injury)
- What is being tested?
- Collection of medical data from ICU patients
- How many people
- 5,000 participants
- Where
- 5 sitesFrance
- Study dates
- 29 Mar 2013to Jan 2050
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients hospitalized in ICU for severe trauma
Who may be able to join
- severe trauma
- and/or traumatic brain injury
- and/or hemorrhage
Who cannot join
- Consent withdrawal
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
Angers University Hospital
Angers, 49000
Sigismond LASOCKI, PhD, MD, Si.Lasocki@chu-angers.fr
Sigismond LASOCKI, PhD, MD
- Recruiting
Nantes University Hospital
Nantes, 44093
Karim ASEHNOUNE, PhD, MD
Antoine ROQUILLY, MD
- Recruiting
Poitiers University Hospital
Poitiers, 86000
Olivier MIMOZ, PhD, MD, o.mimoz@chu-poitiers.fr
Olivier MIMOZ, PhD, MD
- Recruiting
Rennes University Hospital
Rennes, 35000
Yannick MALLEDANT, PhD, MD, yannick.malledant@chu-rennes.fr
Philippe SEGUIN, PhD, MD, philippe.seguin@chu-nantes.fr
- Recruiting
Tours University Hospital
Tours, 37000
Martine FERRANDIERE, MD, ferrandiere@med.univ-tours.fr
Martine FERRANDIERE, MD
About this study
Official title: Prospective Cohort of Severe Trauma Patients Hospitalized in West French Intensive Care Units
The purpose of this observational epidemiological study is to investigate the management and the complications associated with severe trauma. Data will be analysed to answer pre-defined scientific projects and to improve management of these conditions.
Read the detailed description
Pseudonymized data will be collected by study coordinators in a secured e-database.
Cross audit will be performed to check data.
- Being tested
- Collection of medical data from ICU patients
- Keywords
- Severe trauma, traumatic Brain injury, Hemorrhage
- Medical subject headings
- Wounds and Injuries, Brain Injuries, Traumatic, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of medical data from ICU patientsOther
A code will be applied to each patient included. Medical data such as demography, Simplified Acute Physiological Score II (SAPS II), Sequential Organ Failure Assessment (SOFA), procedures and complications during ICU stay will be collected.
| Study group | Role | What they receive |
|---|---|---|
| ICU patients | Patients with severe trauma (with or without brain injury) or Patients with hemorrhagic shock Data concerning the ICU stay will be collected for these patients Receives: Other: Collection of medical data from ICU patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
in ICU stay complications
Nosocomial Infections (epidemiology, risk factors, antibiotic susceptibility of pathogens) Organ failures (incidence, risk factors) Bleeding, hemorrhage Intra-cranial hypertension, brain ischemia Mechanical ventilation weaning, extubation failure
Measured: Within the 28 first days after ICU admission date
Secondary outcomes (2)
Duration of mechanical ventilation
Measured: in ICU (up to 90 days)
ICU length of stay
Measured: in ICU (up to 90 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study start29 Mar 2013
- Primary completionJan 2050 (estimated)
- Study completionJan 2050 (estimated)
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 Severe Trauma (With or Without Traumatic Brain Injury)Studies of the same condition, open and under way.
- 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
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karim ASEHNOUNE, PhD, MD, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426255
- Sponsor's protocol ID
- RC12_0207 cohorte fiche 2
- Status last verified
- Sep 2022
- First submitted
- 21 Apr 2015
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Gourier S, Bouras M, Lakhal K, Launey Y, Leon K, Laffon M, Dahyot-Fizelier C, Roquilly A, Lasocki S, Langeron O, Caillard A; ATLANREA group. Impact of sex on outcomes in critically ill patients with subarachnoid hemorrhage: a secondary analysis of a French prospective cohort study. J Anesth Analg Crit Care. 2026 May 27;6(1):103. doi: 10.1186/s44158-026-00419-2.
PubMed 42204647
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort of Severe Trauma Patients Hospitalized in West French Intensive Care Units
- ClinicalTrials.gov ID
- NCT02426255
- Acronym / sponsor ID
- RC12_0207 cohorte fiche 2
- Keywords
- Severe trauma, traumatic Brain injury, Hemorrhage
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 29 Mar 2013 (actual)
- Primary completion
- Jan 2050 (estimated)
- Study completion
- Jan 2050 (estimated)
- First posted
- 24 Apr 2015 (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.
The purpose of this observational epidemiological study is to investigate the management and the complications associated with severe trauma. Data will be analysed to answer pre-defined scientific projects and to improve management of these conditions.
Detailed description
Pseudonymized data will be collected by study coordinators in a secured e-database.
Cross audit will be performed to check data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU patients | – | Other: Collection of medical data from ICU patientsPatients with severe trauma (with or without brain injury) or Patients with hemorrhagic shock Data concerning the ICU stay will be collected for these patients |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients hospitalized in ICU for severe trauma
Key inclusion criteria (3 listed)
- severe trauma
- and/or traumatic brain injury
- and/or hemorrhage
Key exclusion criteria (1 listed)
- Consent withdrawal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of medical data from ICU patientsA code will be applied to each patient included. Medical data such as demography, Simplified Acute Physiological Score II (SAPS II), Sequential Organ Failure Assessment (SOFA), procedures and complications during ICU stay will be collected. | Other | ICU patients |
Primary outcome
in ICU stay complications
Time frame: Within the 28 first days after ICU admission date
Nosocomial Infections (epidemiology, risk factors, antibiotic susceptibility of pathogens) Organ failures (incidence, risk factors) Bleeding, hemorrhage Intra-cranial hypertension, brain ischemia Mechanical ventilation weaning, extubation failure
2 secondary outcomes
Duration of mechanical ventilation
Time frame: in ICU (up to 90 days)
ICU length of stay
Time frame: in ICU (up to 90 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Derived from this study: PubMed 42204647Gourier S, Bouras M, Lakhal K, Launey Y, Leon K, Laffon M, Dahyot-Fizelier C, Roquilly A, Lasocki S, Langeron O, Caillard A; ATLANREA group. Impact of sex on outcomes in critically ill patients with subarachnoid hemorrhage: a secondary analysis of a French prospective cohort study. J Anesth Analg Crit Care. 2026 May 27;6(1):103. doi: 10.1186/s44158-026-00419-2.
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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.
Karim ASEHNOUNE, PhD, MD study chair
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Trauma (With or Without Traumatic Brain Injury), run by Nantes University Hospital at 5 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karim Asehnoune, PhD, MD (02 40 08 73 80 ext. 33, karim.asehnoune@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
in ICU stay complications (time frame: Within the 28 first days after ICU admission date). 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 NCT02426255, 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 30 Sep 2022.