S100B in the Care of Non-traumatic Headaches in the Emergency Department

Headache Clinical Trial

— S100B-Céph  

Official title:

S100B Protein Measures in the Care of Non-traumatic Headaches in the Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02683304
• Other study ID #: LOCAL/2015/RGG-01
• Secondary ID: 2016-A00013-48
• Status: Completed
• Phase: N/A
• Start date: March 10, 2017
• Est. completion date: March 20, 2020

Study information

• Verified date: July 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: March 20, 2020
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

Inclusion Criteria:

• The patient must have given his/her informed and signed consent

• The patient must be insured or beneficiary of a health insurance plan

• The patient has nontraumatic headache pain with a visual analog scale > 3

Exclusion Criteria:

• The patient is participating in another study

• The patient is in an exclusion period determined by a previous study

• The patient is under judicial protection, under tutorship or curatorship

• The patient refuses to sign the consent

• It is impossible to correctly inform the patient

• The patient is pregnant, parturient, or breastfeeding

• The patient has a contraindication for magnetic resonance imaging

• Patients suffering from the following diseases: Alzheimer's disease, multiple sclerosis, Creutzfeldt-Jakob disease, melanoma, trisomy 21.

Related Conditions & MeSH terms

• Emergencies
• Headache

Intervention

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.

Locations

Country	Name	City	State
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	S100B protein level (ng/ml)		Day 0
Primary	The presence/absence of a clinically significant anomaly on the MRI scan		Days 2-4
Primary	Final diagnostic as established by an expert committee	The diagnostic posed is either "primary headache" or "secondary headache"	Month 1
Secondary	Mortality (yes/no)	"Mortality" refers to whether or not the subject is still alive.	Month 1
Secondary	Length of stay in the emergency department (days)		Month 1
Secondary	Length of stay in the hospital (days)		Month 1
Secondary	White blood cell count in cerebral spinal fluid		Month 1
Secondary	Red blood cell count in cerebral spinal fluid		Month 1
Secondary	Cerebral spinal fluid glucose level		Month 1
Secondary	Cerebral spinal fluid protein level		Month 1
Secondary	Cerebral spinal fluid chloride level		Month 1
Secondary	Presence/absence of enterovirus in cerebral spinal fluid	Based on qualitative result from ELISA laboratory exam.	Month 1
Secondary	Presence/absence of herpes virus in cerebral spinal fluid	Based on qualitative result from ELISA laboratory exam.	Month 1
Secondary	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.		Month 1
Secondary	Secondary headache onset: yes/no	Was there secondary headache onset by month 1?	Month 1