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NCT Number: NCT02426255

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

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.

Recruiting

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Key information

Conditions

Severe Trauma (With or Without Traumatic Brain Injury) Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Hemorrhage Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Angers University Hospital, Angers, France

Loading trial locations.

About this study

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

Cross audit will be performed to check data.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Consent withdrawal

Treatment and study plan

Collection of medical data from ICU patients

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Duration of mechanical ventilation

    Time frame: in ICU (up to 90 days)

  2. ICU length of stay

    Time frame: in ICU (up to 90 days)

Other outcomes

  1. Death

    Time frame: in ICU (up to 90 days)

Study contacts

Contact information is provided by the study sponsor or research team.

Antoine Roquilly, MD

CONTACT

[email protected]

02 40 08 73 80 ext. 33

Karim Asehnoune, PhD, MD

CONTACT

[email protected]

02 40 08 73 80 ext. 33

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Prospective Cohort of Severe Trauma Patients Hospitalized in West French Intensive Care Units

Important dates

Study start
2013
Primary completion
2050
Study completion
2050
First posted
Apr 24, 2015
Registry last updated
Sep 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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