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

Severe Trauma (With or Without Traumatic Brain Injury) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02426255
• Other study ID #: RC12_0207 cohorte fiche 2
• Status: Recruiting
• Start date: March 29, 2013
• Est. completion date: January 2050

Study information

• Verified date: September 2022
• Source: Nantes University Hospital
• Contact: Karim Asehnoune, PhD, MD
• Phone: 02 40 08 73 80
• Email: karim.asehnoune[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Description:

Pseudonymized data will be collected by study coordinators in a secured e-database. Cross audit will be performed to check data.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: January 2050
• Est. primary completion date: January 2050
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Consent withdrawal

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Severe Trauma (With or Without Traumatic Brain Injury)
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
France	Angers University Hospital	Angers
France	Nantes University Hospital	Nantes
France	Poitiers University Hospital	Poitiers
France	Rennes University Hospital	Rennes
France	Tours University Hospital	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Death		in ICU (up to 90 days)
Primary	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	Within the 28 first days after ICU admission date
Secondary	Duration of mechanical ventilation		in ICU (up to 90 days)
Secondary	ICU length of stay		in ICU (up to 90 days)