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

Recruiting

• Conditions: Severe Trauma (With or Without Traumatic Brain Injury)

• Registration Number: NCT02426255
• Lead Sponsor: Nantes University Hospital

Brief 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.

Detailed Description

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

Cross audit will be performed to check data.

Study Timeline

• Study Start: 2013-03-29
• Study First Submitted: 2015-04-21
• Study First Submitted QC: 2015-04-21
• Study First Posted: 2015-04-24
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-09-30
• Primary Completion: 2050-01
• Study Completion: 2050-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

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

Exclusion Criteria

• Consent withdrawal

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
in ICU stay complications	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 Outcome Measures

Name	Time	Method
Duration of mechanical ventilation	in ICU (up to 90 days)
ICU length of stay	in ICU (up to 90 days)

Trial Locations

Locations (5)

Angers University Hospital; 🇫🇷 Angers, France

Nantes University Hospital; 🇫🇷 Nantes, France

Poitiers University Hospital; 🇫🇷 Poitiers, France

Rennes University Hospital; 🇫🇷 Rennes, France

Tours University Hospital; 🇫🇷 Tours, France