Post Traumatic Critical Complications: a Prospective Cohort Study (ATLANREA)

September 29, 2022 updated by: Nantes University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Pseudonymized data will be collected by study coordinators in a secured e-database.

Cross audit will be performed to check data.

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Angers, France, 49000
        • Recruiting
        • Angers University Hospital
        • Principal Investigator:
          • Sigismond LASOCKI, PhD, MD
        • Contact:
      • Nantes, France, 44093
        • Recruiting
        • Nantes University Hospital
        • Sub-Investigator:
          • Raphael CINOTTI, MD
        • Principal Investigator:
          • Karim ASEHNOUNE, PhD, MD
        • Sub-Investigator:
          • Antoine ROQUILLY, MD
      • Poitiers, France, 86000
        • Recruiting
        • Poitiers university hospital
        • Contact:
        • Principal Investigator:
          • Olivier MIMOZ, PhD, MD
      • Rennes, France, 35000
      • Tours, France, 37000
        • Recruiting
        • Tours university Hospital
        • Contact:
        • Principal Investigator:
          • Martine FERRANDIERE, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients hospitalized in ICU for severe trauma

Description

Inclusion Criteria:

  • severe trauma
  • and/or traumatic brain injury
  • and/or hemorrhage

Exclusion Criteria:

  • Consent withdrawal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: Collection of medical data from ICU patients
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within the 28 first days after ICU admission date

Secondary Outcome Measures

Outcome Measure
Time Frame
ICU length of stay
Time Frame: in ICU (up to 90 days)
in ICU (up to 90 days)
Duration of mechanical ventilation
Time Frame: in ICU (up to 90 days)
in ICU (up to 90 days)

Other Outcome Measures

Outcome Measure
Time Frame
Death
Time Frame: in ICU (up to 90 days)
in ICU (up to 90 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Study Chair: Karim ASEHNOUNE, PhD, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2013

Primary Completion (Anticipated)

January 1, 2050

Study Completion (Anticipated)

January 1, 2050

Study Registration Dates

First Submitted

April 21, 2015

First Submitted That Met QC Criteria

April 21, 2015

First Posted (Estimate)

April 24, 2015

Study Record Updates

Last Update Posted (Actual)

September 30, 2022

Last Update Submitted That Met QC Criteria

September 29, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC12_0207 cohorte fiche 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Severe Trauma (With or Without Traumatic Brain Injury)

Clinical Trials on Collection of medical data from ICU patients

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe