Back to resultsClinical and Biological Strokes Collection in Reunion Island (CoBRA)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Réunion
Study Type
Interventional
Intervention
Biological Collection
Sponsored by
About this trial
This is an interventional diagnostic trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- affiliated to a social security scheme
- clinical signs suggestive of stroke : hemiparesis or hemiplegia, unilateral sensory disorder, language disorder, balance disorder, dizziness, loss of total or partial bilateral or monocular vision, sudden neurological deficit
Exclusion Criteria:
- current pregnancy
- Recent clinical history of head trauma
- patients aged < 18 years old
- patient under guardianship or curatorship
- Person deprived of liberty
Sites / Locations
- CHU de La Réunion
- CHU de La Réunion
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
A blood sample (10 ml) will be taken for each patient included in the study
Outcomes
Primary Outcome Measures
clinico-biological score
area under the diagnostic score curve identifying ischemic stroke, stroke hemorrhagic or mimics.
Secondary Outcome Measures
Full Information
NCT ID
NCT05598138
First Posted
October 19, 2022
Last Updated
September 28, 2023
Sponsor
Centre Hospitalier Universitaire de la Réunion
1. Study Identification
Unique Protocol Identification Number
NCT05598138
Brief Title
Clinical and Biological Strokes Collection in Reunion Island
Acronym
CoBRA
Official Title
Clinical and Biological Strokes Collection in Reunion Island
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 22, 2021 (Actual)
Primary Completion Date
June 21, 2023 (Actual)
Study Completion Date
June 21, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de la Réunion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cross-sectional regional multicenter hospital study of all neurological events (stroke, AIT and mimics) for diagnostic and prognostic purposes. Cost of illness study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
795 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
A blood sample (10 ml) will be taken for each patient included in the study
Intervention Type
Biological
Intervention Name(s)
Biological Collection
Intervention Description
A blood sample (10 ml) will be taken for each patient included in the study.
Primary Outcome Measure Information:
Title
clinico-biological score
Description
area under the diagnostic score curve identifying ischemic stroke, stroke hemorrhagic or mimics.
Time Frame
24 hours after the stroke
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
affiliated to a social security scheme
clinical signs suggestive of stroke : hemiparesis or hemiplegia, unilateral sensory disorder, language disorder, balance disorder, dizziness, loss of total or partial bilateral or monocular vision, sudden neurological deficit
Exclusion Criteria:
current pregnancy
Recent clinical history of head trauma
patients aged < 18 years old
patient under guardianship or curatorship
Person deprived of liberty
Facility Information:
Facility Name
CHU de La Réunion
City
Saint-Denis
ZIP/Postal Code
97400
Country
Réunion
Facility Name
CHU de La Réunion
City
Saint-Pierre
ZIP/Postal Code
97448
Country
Réunion
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical and Biological Strokes Collection in Reunion Island
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