- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02714387
Non Traumatic Neuro-Vascular Diseases Critical Complications : a Prospective Cohort Study (ATLANREA)
September 29, 2022 updated by: Nantes University Hospital
Prospective Cohort of Patients Hospitalized in West French Intensive Care Units.
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
5000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Karim Asehnoune, PhD, MD
- Phone Number: 33 02 40 08 73 80
- Email: karim.asehnoune@chu-nantes.fr
Study Contact Backup
- Name: Antoine Roquilly, MD
- Phone Number: 33 02 40 08 73 80
- Email: antoine.roquilly@chu-nantes.fr
Study Locations
-
-
-
Angers, France, 49000
- Recruiting
- Angers University Hospital
-
Contact:
- Sigismond Lasocki, PhD, MD
- Email: sigismond@lasocki.com
-
Principal Investigator:
- Sigismond LASOCKI, PhD, MD
-
Brest, France, 29000
- Recruiting
- CHU de Brest La Cavale Blanche
-
Contact:
- Olivier HUET, MD, PhD
- Email: olivier.huet@chu-brest.fr
-
Principal Investigator:
- Olivier Huet, MD, PhD
-
Nantes, France, 44093
- Recruiting
- Nantes University Hospital
-
Contact:
- Karim Asehnoune, PhD, MD
- Phone Number: 33 02 40 08 73 80
- Email: karim.asehnoune@chu-nantes.fr
-
Contact:
- Antoine Roquilly, MD
- Phone Number: 33 02 40 08 73 80
- Email: antoine.roquilly@chu-nantes.fr
-
Sub-Investigator:
- Raphael CINOTTI, MD
-
Poitiers, France, 86000
- Recruiting
- Poitiers University Hospital
-
Contact:
- Olivier MIMOZ, PhD, MD
- Email: o.mimoz@chu-poitiers.fr
-
Contact:
- Claire Dahyot, MD
- Email: claire.dahyot@chu-poitiers.fr
-
Principal Investigator:
- Olivier MIMOZ, PhD, MD
-
Sub-Investigator:
- Claire Dahyot, MD
-
Rennes, France, 35000
- Recruiting
- Rennes University Hospital
-
Contact:
- Yannick MALLEDANT, PhD, MD
- Email: yannick.malledant@chu-rennes.fr
-
Contact:
- Philippe Seguin, PhD, MD
- Email: philippe.seguin@chu-rennes.fr
-
Principal Investigator:
- Yannick Malledant, PhD, MD
-
Sub-Investigator:
- Philppe Seguin, PhD, MD
-
Tours, France, 37000
- Recruiting
- Tours University Hospital
-
Contact:
- Martine FERRANDIERE, MD
- Email: ferrandiere@med.univ-tours.fr
-
Principal Investigator:
- Martine FERRANDIERE, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients hospitalized in ICU for Non Traumatic Neuro-Vascular Diseases
Description
Inclusion Criteria:
- Non Traumatic Neuro-Vascular Diseases
Exclusion Criteria:
- Consent withdrawal
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
ICU patients
Patients with Non Traumatic Neuro-Vascular Diseases.
Medical data concerning ICU stay will be collected.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Within the first 28 days after ICU admission date
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Duration in mechanical ventilation
Time Frame: in ICU (up to 90 days)
|
in ICU (up to 90 days)
|
|
ICU length of stay
Time Frame: in ICU (up to 90 days)
|
in ICU (up to 90 days)
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Death
Time Frame: in ICU (up to 180 days)
|
in ICU (up to 180 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Karim ASEHNOUNE, PhD, MD
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Anticipated)
January 1, 2050
Study Completion (Anticipated)
January 1, 2050
Study Registration Dates
First Submitted
March 16, 2016
First Submitted That Met QC Criteria
March 16, 2016
First Posted (Estimate)
March 21, 2016
Study Record Updates
Last Update Posted (Actual)
September 30, 2022
Last Update Submitted That Met QC Criteria
September 29, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC12_0207 cohorte fiche 1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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