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

• Sponsor: Nantes University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02426255
• Collaborator: (none)
• Enrollment: 5,000
• Locations: 5
• Anticipated Duration (Months): 441.1
• Patients Per Site: 1000
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Trauma (With or Without Traumatic Brain Injury)	Other: Collection of medical data from ICU patients

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

• Study Type: Observational
• Anticipated Enrollment: 5000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective Cohort of Severe Trauma Patients Hospitalized in West French Intensive Care Units
• Actual Study Start Date: Mar 29, 2013
• Anticipated Primary Completion Date: Jan 1, 2050
• Anticipated Study Completion Date: Jan 1, 2050

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Duration of mechanical ventilation [in ICU (up to 90 days)]

2. ICU length of stay [in ICU (up to 90 days)]

Other Outcome Measures

1. Death [in ICU (up to 90 days)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• severe trauma

• and/or traumatic brain injury

• and/or hemorrhage

Exclusion Criteria:

• Consent withdrawal

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Angers University Hospital	Angers		France	49000
2	Nantes University Hospital	Nantes		France	44093
3	Poitiers University Hospital	Poitiers		France	86000
4	Rennes University Hospital	Rennes		France	35000
5	Tours University Hospital	Tours		France	37000

Sponsors and Collaborators

• Nantes University Hospital

Investigators

• Study Chair: Karim ASEHNOUNE, PhD, MD,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nantes University Hospital
• ClinicalTrials.gov Identifier: NCT02426255
• Other Study ID Numbers: RC12_0207 cohorte fiche 2
• First Posted: Apr 24, 2015
• Last Update Posted: Jun 4, 2020
• Last Verified: Jun 1, 2020

• Keywords provided by Nantes University Hospital: Severe trauma; traumatic Brain injury; Hemorrhage
• Additional relevant MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries

Study Results

No Results Posted as of Jun 4, 2020