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S100B in the Care of Non-traumatic Headaches in the Emergency Department (S100B-Céph)

Primary Purpose

Headache

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Plasma S100B levels at inclusion
Magnetic resonance imaging
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Headache

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHRU de Nîmes - Hôpital Universitaire Carémeau

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

The study population

Arm Description

The study population consists of consecutive headache patients (visual analogue scale > 3) presenting at the emergency department of the Nîmes University Hospital

Outcomes

Primary Outcome Measures

S100B protein level (ng/ml)
The presence/absence of a clinically significant anomaly on the MRI scan
Final diagnostic as established by an expert committee
The diagnostic posed is either "primary headache" or "secondary headache"

Secondary Outcome Measures

Mortality (yes/no)
"Mortality" refers to whether or not the subject is still alive.
Length of stay in the emergency department (days)
Length of stay in the hospital (days)
White blood cell count in cerebral spinal fluid
Red blood cell count in cerebral spinal fluid
Cerebral spinal fluid glucose level
Cerebral spinal fluid protein level
Cerebral spinal fluid chloride level
Presence/absence of enterovirus in cerebral spinal fluid
Based on qualitative result from ELISA laboratory exam.
Presence/absence of herpes virus in cerebral spinal fluid
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.
Secondary headache onset: yes/no
Was there secondary headache onset by month 1?

Full Information

First Posted
January 19, 2016
Last Updated
July 13, 2020
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT02683304
Brief Title
S100B in the Care of Non-traumatic Headaches in the Emergency Department
Acronym
S100B-Céph
Official Title
S100B Protein Measures in the Care of Non-traumatic Headaches in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 10, 2017 (Actual)
Primary Completion Date
March 20, 2020 (Actual)
Study Completion Date
March 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The study population
Arm Type
Experimental
Arm Description
The study population consists of consecutive headache patients (visual analogue scale > 3) presenting at the emergency department of the Nîmes University Hospital
Intervention Type
Biological
Intervention Name(s)
Plasma S100B levels at inclusion
Intervention Description
Patients will have blood drawn to measure plasma S100B levels at inclusion.
Intervention Type
Device
Intervention Name(s)
Magnetic resonance imaging
Intervention Description
If not performed under emergency conditions, patients will have an MRI on days 2-4.
Primary Outcome Measure Information:
Title
S100B protein level (ng/ml)
Time Frame
Day 0
Title
The presence/absence of a clinically significant anomaly on the MRI scan
Time Frame
Days 2-4
Title
Final diagnostic as established by an expert committee
Description
The diagnostic posed is either "primary headache" or "secondary headache"
Time Frame
Month 1
Secondary Outcome Measure Information:
Title
Mortality (yes/no)
Description
"Mortality" refers to whether or not the subject is still alive.
Time Frame
Month 1
Title
Length of stay in the emergency department (days)
Time Frame
Month 1
Title
Length of stay in the hospital (days)
Time Frame
Month 1
Title
White blood cell count in cerebral spinal fluid
Time Frame
Month 1
Title
Red blood cell count in cerebral spinal fluid
Time Frame
Month 1
Title
Cerebral spinal fluid glucose level
Time Frame
Month 1
Title
Cerebral spinal fluid protein level
Time Frame
Month 1
Title
Cerebral spinal fluid chloride level
Time Frame
Month 1
Title
Presence/absence of enterovirus in cerebral spinal fluid
Description
Based on qualitative result from ELISA laboratory exam.
Time Frame
Month 1
Title
Presence/absence of herpes virus in cerebral spinal fluid
Description
Based on qualitative result from ELISA laboratory exam.
Time Frame
Month 1
Title
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
Title
Secondary headache onset: yes/no
Description
Was there secondary headache onset by month 1?
Time Frame
Month 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romain Genre Grandpierre, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes Cedex 09
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

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

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