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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date March 16, 2016
First Posted Date March 21, 2016
Last Update Posted Date September 15, 2017
Study Start Date February 2013
Estimated Primary Completion Date January 2050   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 16, 2016)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 16, 2016)
  • Duration in mechanical ventilation [ Time Frame: in ICU (up to 90 days) ]
  • ICU length of stay [ Time Frame: in ICU (up to 90 days) ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 16, 2016)
Death [ Time Frame: in ICU (up to 180 days) ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Non Traumatic Neuro-Vascular Diseases Critical Complications : a Prospective Cohort Study
Official Title Prospective Cohort of Patients Hospitalized in West French Intensive Care Units.
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Plasma, serum, peripheral blood mononuclear cells, RNA
Sampling Method Non-Probability Sample
Study Population Patients hospitalized in ICU for Non Traumatic Neuro-Vascular Diseases
Condition Non Traumatic Acute Brain Injury
Intervention 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.
Study Groups/Cohorts ICU patients
Patients with Non Traumatic Neuro-Vascular Diseases. Medical data concerning ICU stay will be collected.
Intervention: Other: Collection of medical data
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 14, 2017)
3000
Original Estimated Enrollment
 (submitted: March 16, 2016)
5000
Estimated Study Completion Date January 2050
Estimated Primary Completion Date January 2050   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Non Traumatic Neuro-Vascular Diseases

Exclusion Criteria:

  • Consent withdrawal
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
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
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02714387
Other Study ID Numbers RC12_0207 cohorte fiche 1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Nantes University Hospital
Study Sponsor Nantes University Hospital
Collaborators Not Provided
Investigators
Study Chair: Karim Asehnoune, PhD, MD
PRS Account Nantes University Hospital
Verification Date September 2017