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

This study is currently recruiting participants.
Verified August 2017 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
ClinicalTrials.gov Identifier:
NCT02683304
First Posted: February 17, 2016
Last Update Posted: August 22, 2017
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.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
  Purpose

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 Intervention
Headache Biological: Plasma S100B levels at inclusion Device: Magnetic resonance imaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: S100B Protein Measures in the Care of Non-traumatic Headaches in the Emergency Department

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • 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"


Secondary Outcome Measures:
  • 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?


Estimated Enrollment: 80
Actual Study Start Date: March 10, 2017
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683304


Contacts
Contact: Romain Genre Grandpierre, MD +33.(0)4.66.68.30.50 romainsbs@hotmail.com
Contact: Carey Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
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         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Romain Genre Grandpierre, MD Centre Hospitalier Universitaire de Nîmes
  More Information

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02683304     History of Changes
Other Study ID Numbers: LOCAL/2015/RGG-01
2016-A00013-48 ( Other Identifier: RCB number )
First Submitted: January 19, 2016
First Posted: February 17, 2016
Last Update Posted: August 22, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Emergencies
Headache
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms