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.
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
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
- 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),
- 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:
- 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),
- 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.
- Conditions
- Minor/Mild Traumatic Brain Injury
- 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.
Relationship between S100 levels and the diagnosis of minor/moderate TBI by craniocerebral tomodensitometry
Measured: during the study
Secondary outcomes (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.
- First posted14 Jan 2009 (estimated)
- Study startJun 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minor/Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Jean-Louis Beaudeux, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT00822445
- Acronym / sponsor ID
- S100 / IC0601
- Conditions
- Minor/Mild Traumatic Brain Injury
- Keywords
- Biomarker, S100 protein, Traumatic brain injury, Craniocerebral tomodensitometry, Neurological sequelae
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Jun 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 14 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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),
- 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
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:
- 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),
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Minor/mild traumatic brain injury
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- Age <18 or> 80 years
- Glasgow score at admission <9
- No prescription of cerebral tomodensitometry
- Multiple, fractures
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relationship between S100 levels and the diagnosis of minor/moderate TBI by craniocerebral tomodensitometry
Time frame: during the study
1 secondary outcome
Positive and negative predictive values of S100 level for the diagnosis and the prognosis of minor/moderate TBI
Time frame: during the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Louis Beaudeux, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
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.