Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2026-02-24 @ 3:52 AM
Study NCT ID:
NCT02683304
Status:
COMPLETED
Last Update Posted:
2025-12-01
First Post:
2016-01-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S100B in the Care of Non-traumatic Headaches in the Emergency Department
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Organization:
Study Overview
Official Title:
S100B Protein Measures in the Care of Non-traumatic Headaches in the Emergency Department
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
S100B-Céph
Brief Summary:
The main objective of this pilot study is to make a first assessment of the discriminating ability of a dosage of S100B protein for differential diagnosis between primary headaches and secondary headaches.
For this, the investigators will compare serum S100B protein between two groups of headache patients presenting at the emergency department: 1 group of primary headache patients and 1 group of secondary headache patients.
If the difference between the two groups proves potentially discriminating, the investigators will seek to determine the discriminating ability of the S100B protein by calculating the area under the ROC curve.
The reference diagnostic will be set at one month across the entire clinical picture and imaging by an expert committee composed of a neurologist, a radiologist and an emergency physician.
For this, the investigators will compare serum S100B protein between two groups of headache patients presenting at the emergency department: 1 group of primary headache patients and 1 group of secondary headache patients.
If the difference between the two groups proves potentially discriminating, the investigators will seek to determine the discriminating ability of the S100B protein by calculating the area under the ROC curve.
The reference diagnostic will be set at one month across the entire clinical picture and imaging by an expert committee composed of a neurologist, a radiologist and an emergency physician.
Detailed Description:
The secondary objectives of this study are:
A. To seek an association between S100B protein levels and the onset of pain depending on whether it is more or less than 3 hours.
B. To assess the association between S100B protein levels and mortality at day 28.
C. To evaluate the association between S100B protein levels and hospital care: average length of stay in the emergency department, lumbar puncture, brain imaging, average length of hospital stay.
D. To evaluate the prognostic value of determination of S100B protein on the occurrence of a secondary headache at 1 month.
A. To seek an association between S100B protein levels and the onset of pain depending on whether it is more or less than 3 hours.
B. To assess the association between S100B protein levels and mortality at day 28.
C. To evaluate the association between S100B protein levels and hospital care: average length of stay in the emergency department, lumbar puncture, brain imaging, average length of hospital stay.
D. To evaluate the prognostic value of determination of S100B protein on the occurrence of a secondary headache at 1 month.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2016-A00013-48 | OTHER | ANSM | View |