Trials / Completed
CompletedNCT02683304
S100B in the Care of Non-traumatic Headaches in the Emergency Department
S100B Protein Measures in the Care of Non-traumatic Headaches in the Emergency Department
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 81 (actual)
- Sponsor
- Centre Hospitalier Universitaire de Nīmes · Academic / Other
- Sex
- All
- Age
- 18 Years – 59 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Plasma S100B levels at inclusion | Patients will have blood drawn to measure plasma S100B levels at inclusion. |
| DEVICE | Magnetic resonance imaging | If not performed under emergency conditions, patients will have an MRI on days 2-4. |
Timeline
- Start date
- 2017-03-10
- Primary completion
- 2020-03-20
- Completion
- 2020-03-20
- First posted
- 2016-02-17
- Last updated
- 2025-12-01
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT02683304. Inclusion in this directory is not an endorsement.