S100B in the Care of Non-traumatic Headaches in the Emergency Department (S100B-Céph)
|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: NCT02683304|
Recruitment Status : Recruiting
First Posted : February 17, 2016
Last Update Posted : August 22, 2017
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.
|Condition or disease||Intervention/treatment|
|Headache||Biological: Plasma S100B levels at inclusion Device: Magnetic resonance imaging|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||S100B Protein Measures in the Care of Non-traumatic Headaches in the Emergency Department|
|Actual Study Start Date :||March 10, 2017|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2018|
Experimental: The study population
The study population consists of consecutive headache patients (visual analogue scale > 3) presenting at the emergency department of the Nîmes University Hospital
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.
- S100B protein level (ng/ml) [ Time Frame: Day 0 ]
- The presence/absence of a clinically significant anomaly on the MRI scan [ Time Frame: Days 2-4 ]
- Final diagnostic as established by an expert committee [ Time Frame: Month 1 ]The diagnostic posed is either "primary headache" or "secondary headache"
- Mortality (yes/no) [ Time Frame: Month 1 ]"Mortality" refers to whether or not the subject is still alive.
- Length of stay in the emergency department (days) [ Time Frame: Month 1 ]
- Length of stay in the hospital (days) [ Time Frame: Month 1 ]
- White blood cell count in cerebral spinal fluid [ Time Frame: Month 1 ]
- Red blood cell count in cerebral spinal fluid [ Time Frame: Month 1 ]
- Cerebral spinal fluid glucose level [ Time Frame: Month 1 ]
- Cerebral spinal fluid protein level [ Time Frame: Month 1 ]
- Cerebral spinal fluid chloride level [ Time Frame: Month 1 ]
- Presence/absence of enterovirus in cerebral spinal fluid [ Time Frame: Month 1 ]Based on qualitative result from ELISA laboratory exam.
- Presence/absence of herpes virus in cerebral spinal fluid [ Time Frame: Month 1 ]Based on qualitative result from ELISA laboratory exam.
- Presence/absence of cerebral imaging indicating an ischemic or hemorrhagic stroke, subarachnoid hemorrhage, an expansive process, cerebral trombophlebitis cerebral or other abnormalities suggestive of a secondary cause of headache. [ Time Frame: Month 1 ]
- Secondary headache onset: yes/no [ Time Frame: Month 1 ]Was there secondary headache onset by month 1?
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683304
|Contact: Romain Genre Grandpierre, MD||+33.(0)firstname.lastname@example.org|
|Contact: Carey Suehs, PhD||+33.(0)email@example.com|
|CHRU de Nîmes - Hôpital Universitaire Carémeau||Recruiting|
|Nîmes Cedex 09, France, 30029|
|Principal Investigator: Romain Genre Grandpierre, MD|
|Sub-Investigator: Xavier Bobbia, MD|
|Sub-Investigator: Rémi Perrin-Bayard, MD|
|Sub-Investigator: Stéphane Pommet, MD|
|Sub-Investigator: Alexandre Moreau, MD|
|Sub-Investigator: Pierre-Géraud Claret, MD|
|Sub-Investigator: Yan Bodin, MD|
|Principal Investigator:||Romain Genre Grandpierre, MD||Centre Hospitalier Universitaire de Nîmes|