AzTrials
AzTrials

Minor/Mild Traumatic Brain InjuryS100NCT00822445

S100 Protein in Minor/Mild Traumatic Brain Injury

An observational study of Minor/Mild Traumatic Brain Injury, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Traumatic brain injury (TBI) is a Public Health problem, because of the numbers of events (more than 200,000 per year in France). Craniocerebral tomodensitometry (CCT) is widely used for the diagnosis of minor/mild TBI, but both the access to the CCT and the cost of this imagery are critical factors. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Minor/Mild Traumatic Brain Injury
How many people
500 participants
Where
1 siteFrance
Study dates
Jun 2008to May 2010
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Minor/mild traumatic brain injury

Who may be able to join

  • Patient with suspected minor/mild TBI justifying a cerebral tomodensitometry (blow to the head, concussion ± treatment by AVK or antiaggregants
  • Age above 65 years ± temporary loss of consciousness [<10 minutes] ±amnesia ± major headache ±vomiting
  • Glasgow score at admission sup or equal to 9
  • Admission within 3 hours after to the traumatic event
  • Cerebral tomodensitometry within 6 hours after admission
  • Informed consent of the subject

Who cannot join

  • Age <18 or> 80 years
  • Glasgow score at admission <9
  • No prescription of cerebral tomodensitometry
  • Multiple, fractures
  • Pregnancy
  • Acute (meningitis...) or chronic (encephalitis, all neurodegenerative diseases ...) neurological disease
Show all 9Show fewer
  • Renal failure (creatinine> 130 µmol/L)
  • Malignant melanoma
  • Loss of consciousness> 10 minutes

Trial locations and contacts

1 site in 1 country.

France1 site
  • Groupe Hospitalier Pitié-Salpêtrière - Charles Foix

    Ivry-sur-Seine, 94200

Other trials in France

About this study

Official title: Diagnostic Value and Prognostic Value of the Blood Level Determination of S100 Protein in Minor or Mild Traumatic Brain Injury (GCS Glasgow Score 9 to 15).

Traumatic brain injury (TBI) is a Public Health problem, because of the numbers of events (more than 200,000 per year in France). Craniocerebral tomodensitometry (CCT) is widely used for the diagnosis of minor/mild TBI, but both the access to the CCT and the cost of this imagery are critical factors. We hypothesized that the blood level measurement of S100 protein (S100), a neurological biomarker of cerebral injury, would help to the clinical evaluation of minor/mild head injury events, and would be an economic alternative to CCT for the diagnosis of these pathologies. In addition, a part of the study will explore the prognostic value of such blood level S100 determination for the evaluation of medical/social consequences of minor/mild TBI.

Medical objective of the study:

Read more
  1. to assess the contribution of early determination (to medical care) of S100 for the diagnosis of minor/moderate TBI (TCCMM - Glasgow sup or equal to 9),
  2. to determine the usefulness of a second dosage three hours later for the medical decision.

In other words, to compare S100 biomarker and CCT considered as a reference ( "Gold Standard") for the diagnosis or exclusion of TCCMM, and to precise its terms of use.

Economic objective:

to conduct a cost-effectiveness study of blood level determination of S100 vs. CCT for the diagnosis of minor/moderate TBI and its medical/social consequences

Read the detailed description

Nearly two hundred thousand head injury cases (Traumatic Brain Injury - TBI) are reported each year in France. Less than 5% are severe, defined by a Glasgow score (GCS) above 9. Epidemiological studies indicate that TBI is the fourth leading cause of death and disability in industrialized countries. Major causes of mild/minor TBI are falls and domestic trauma in the elderly or children, and sports accidents. The minor/mild brai injury (MBI) may represent 5 to 10% of emergency consultations in the UAA.

The severity of a head injury is assessed by the Glasgow Coma Scale (GCS), and TBI are divided into three groups: minor (13-15), moderate (9-12) , severe (3-8). Definition of TCC has considerably evolved over the past 20 years, to take into account the pathophysiologic lesions secondary is related to systemic factors (hypotension, hypoxia ...) and intracranial factors ( intracranial hypertension, seizures committals ...). These side events, occurring within hours or days after the primary injury caused by an impact (contusion, hematoma, deceleration), increase the morbidity of the initial event, and must therefore be detected both early and fully.

The diagnosis of TBI requires imaging data such as craniocerebral tomography (CCT), which will be renewed after 24 hours and if necessary the following day. Until now, no pertinent biological marker was proposed to complete the clinical/imagery investigation of mild/moderate TBI.

S100B protein (S100) is a constitutive protein of glial cells, whose physiological functions are both intracellular, i.e. intracytosolic calcium binding, and extracellular, e.g. by promoting neuritic proliferation and/or neuronal apoptosis. Due to specificity of its cellular expression, S100B protein is a useful biological marker of acute neurological disorders, such as ischemic or haemorrhagic stroke, and traumatic head injury. hemorrhage, ischemic stroke) or traumatic (TCC). Plasma S100 is significantly increased in subjects with a major TCC, but also in the majority of minor or moderate TBI. A prognostic value of S100 also was suggested : patients who exhibited medical or social sequelae after several months after TBI also shoed high plasma levels of S100 in the first hours of the head injury. Such results of international clinical studies proposed S100 as a biomarker of diffuse brain injury, and indicate the importance of early determination of plasma concentration of S100 and its integration among the other elements of diagnosis (imaging) for assessing the severity of trauma and its short and long terms.

Medical objective of the study:

  1. to assess the contribution of early determination (to medical care) of S100 for the diagnosis of minor/moderate TBI (TCCMM - Glasgow sup or equal to 9),
  2. to determine the usefulness of a second dosage three hours later for the medical decision.

In other words, to compare S100 biomarker and CCT considered as a reference ( "Gold Standard") for the diagnosis or exclusion of TCCMM, and to precise its terms of use.

Economic objective:

to conduct a cost-effectiveness study of blood level determination of S100 vs. CCT for the diagnosis of minor/moderate TBI and its medical/social consequences.

Keywords
Biomarker, S100 protein, Traumatic brain injury, Craniocerebral tomodensitometry, Neurological sequelae
Medical subject headings
Brain Injuries, Traumatic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relationship between S100 levels and the diagnosis of minor/moderate TBI by craniocerebral tomodensitometry

    Measured: during the study

Secondary outcomes (1)
  1. Positive and negative predictive values of S100 level for the diagnosis and the prognosis of minor/moderate TBI

    Measured: during the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2009 (estimated)
  2. Study startJun 2008
  3. Primary completionMay 2010
  4. Study completionMay 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00822445
Sponsor's protocol ID
IC0601
Acronym
S100
Status last verified
Feb 2008
First submitted
13 Jan 2009
Last updated
31 Oct 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Minor/Mild Traumatic Brain Injury, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relationship between S100 levels and the diagnosis of minor/moderate TBI by craniocerebral tomodensitometry (time frame: during the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2012.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in