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Non Traumatic Neuro-Vascular Diseases Critical Complications : a Prospective Cohort Study (ATLANREA)

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ClinicalTrials.gov Identifier: NCT02714387
Recruitment Status : Recruiting
First Posted : March 21, 2016
Last Update Posted : September 15, 2017
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:
The purpose of this observational epidemiological study is to investigate the management and the complications associated with Non Traumatic Neuro-Vascular Diseases. Data will be analysed to answer pre-defined scientific projects and to improve management of these conditions.

Condition or disease Intervention/treatment
Non Traumatic Acute Brain Injury Other: Collection of medical data

Detailed Description:
Anonymous data will be collected by study coordinators in a secured e-database. Cross audit will be performed to check data.

Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Cohort of Patients Hospitalized in West French Intensive Care Units.
Study Start Date : February 2013
Estimated Primary Completion Date : January 2050
Estimated Study Completion Date : January 2050

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
ICU patients
Patients with Non Traumatic Neuro-Vascular Diseases. Medical data concerning ICU stay will be collected.
Other: Collection of medical data
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 Outcome Measures :
  1. in ICU stay complications [ Time Frame: Within the first 28 days after ICU admission date ]
    Hospital acquired infections (epidemiology, risk factors, antibiotic susceptibility of pathogens), Organ failures (incidence, risks factors), Bleeding, Hemorrhage Intra-Cranial Hypertension, Brain Ischemia, Mechanical ventilation weaning, Extubation failure


Secondary Outcome Measures :
  1. Duration in mechanical ventilation [ Time Frame: in ICU (up to 90 days) ]
  2. ICU length of stay [ Time Frame: in ICU (up to 90 days) ]

Other Outcome Measures:
  1. Death [ Time Frame: in ICU (up to 180 days) ]

Biospecimen Retention:   Samples Without DNA
Plasma, serum, peripheral blood mononuclear cells, RNA


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients hospitalized in ICU for Non Traumatic Neuro-Vascular Diseases
Criteria

Inclusion Criteria:

  • Non Traumatic Neuro-Vascular Diseases

Exclusion Criteria:

  • Consent withdrawal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714387


Contacts
Contact: Karim Asehnoune, PhD, MD 02 40 08 73 80 ext 33 karim.asehnoune@chu-nantes.fr
Contact: Antoine Roquilly, MD 02 40 08 73 80 ext 33 antoine.roquilly@chu-nantes.fr

Locations
France
Angers University Hospital Recruiting
Angers, France, 49000
Contact: Sigismond Lasocki, PhD, MD       sigismond@lasocki.com   
Principal Investigator: Sigismond Lasocki, PhD, MD         
CHU de Brest La Cavale Blanche Recruiting
Brest, France, 29000
Contact: Olivier Huet, MD, PhD       olivier.huet@chu-brest.fr   
Principal Investigator: Olivier Huet, MD, PhD         
Nantes University Hospital Recruiting
Nantes, France, 44093
Contact: Karim Asehnoune, PhD, MD    02 40 08 73 80 ext 33    karim.asehnoune@chu-nantes.fr   
Contact: Antoine Roquilly, MD    02 40 08 73 80 ext 33    antoine.roquilly@chu-nantes.fr   
Poitiers University Hospital Recruiting
Poitiers, France, 86000
Contact: Olivier Mimoz, PhD, MD       o.mimoz@chu-poitiers.fr   
Contact: Claire Dahyot, MD       claire.dahyot@chu-poitiers.fr   
Principal Investigator: Olivier Mimoz, PhD, MD         
Sub-Investigator: Claire Dahyot, MD         
Rennes University Hospital Recruiting
Rennes, France, 35000
Contact: Yannick Malledant, PhD, MD       yannick.malledant@chu-rennes.fr   
Contact: Philippe Seguin, PhD, MD       philippe.seguin@chu-rennes.fr   
Principal Investigator: Yannick Malledant, PhD, MD         
Sub-Investigator: Philppe Seguin, PhD, MD         
Tours University Hospital Recruiting
Tours, France, 37000
Contact: Martine Ferrandière, MD       ferrandiere@med.univ-tours.fr   
Principal Investigator: Martine Ferrandière, MD         
Sponsors and Collaborators
Nantes University Hospital
Investigators
Study Chair: Karim Asehnoune, PhD, MD

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02714387     History of Changes
Other Study ID Numbers: RC12_0207 cohorte fiche 1
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017

Keywords provided by Nantes University Hospital:
Non traumatic acute brain injury

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries