Mild Traumatic Brain InjuryPROMETHEENCT03313505
PROtein S100B for Mild Trauma of the HEad in Emergency Patients
An observational study of Mild Traumatic Brain Injury, run by Centre Hospitalier Princesse Grace at 15 sites in 2 countries.
Trial summary
Brain injury is a frequent purpose for consultation in emergency services. Management of brain injury is time and resource consuming, combining clinical monitoring and imaging. The stage prior to the management of the victims of brain injury is stratification of the severity, potential or proven. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- S100B protein dosage and Brain CT scan
- How many people
- 787 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 14 May 2018to 22 Jul 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted to the emergency unit with mild brain injury and meeting the inclusion criteria
Who may be able to join
- Adult Patients
- Victims of mild head trauma at risk of complication :
- o Adult patients with head trauma with:
- retrograde amnesia of more than 30 minutes, or
- loss of consciousness or amnesia of the facts associated with:
- Either a risky mechanism (pedestrian overturned by a motor vehicle, ejection of a vehicle, drop of more than one meter),
Show all 10Show fewer
- either An age> 65 years,
- Either clotting disorders, including platelet aggregation therapy.
- either Glasgow Score to 15
- Admitted to the emergency department within three hours of the traumatic event.
Who cannot join
- Refusal to participate at the study
- Patients with obstacle to 7 days follow up
- Pregnant women
- Patients not subject to an health insurance scheme in France or Monaco.
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
France14 sites
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, 63003
AP-HP Centre Hospitalier Universitaire Henri-Mondor
Créteil, 94000
Hospices Civils de Lyon - Pôle Est
Lyon, 69002
AP-HM La Timone
Marseille, 13915
Centre Hospitalier de Metz-Thionville
Metz, 57085
Centre Hospitalier Universitaire de Nice, Hôpital Pasteur
Nice, 06000
Centre Hospitalier Universitaire de Nîmes - Hôpital Carémeau
Nîmes, 30029
AP-HP Nord Lariboisière
Paris, 75010
AP-HP Sud Pitié-Salpêtrière
Paris, 75013
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86000
Hôpital Charles Nicolle
Rouen, 76031
CHU de Strasbourg
Strasbourg
HIA Sainte Anne
Toulon, 83800
Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan
Toulouse, 31059
About this study
Brain injury is a frequent purpose for consultation in emergency services. Management of brain injury is time and resource consuming, combining clinical monitoring and imaging.
The stage prior to the management of the victims of brain injury is stratification of the severity, potential or proven.
Read more
Severe brain injury requires emergent brain CT-scan, ideally within one hour of the first medical contact. Patients requiring this strategy present with focused neurological deficit, Glasgow score <15 to 2 hours after the trauma, suspicion of open fracture of the skull or dish pan fracture, any signs of fracture of the skull base (hemotympanum, bilateral peri-orbital ecchymosis), otorrhea or rhinorrhea of cerebrospinal fluid, more than one episode of vomiting in adults, and posttraumatic convulsion. Patients benefiting from anticoagulant therapy are included in this category.
Victims of brain injury that do not fall into this category are considered less critical.
By definition, mild traumatic brain injury :
- a trauma of the cephalic extremity :
- whose Glasgow score (30 min after the trauma or during the consultation) is 13-15,
- associated with one or more of the following: confusion; disorientation; loss of consciousness of 30 min or less; post-traumatic amnesia of less than 24 hours; other transient neurological abnormalities (focal signs, epileptic seizures, non-surgical intracranial lesion).
Among these patients, some are considered at risk of developing intracerebral lesions. Nevertheless, it should be noted that the prevalence of hemorrhagic complications is radically different between patients with a Glasgow score of 13 and those with a score of 15. Thus, the recommendations suggest a brain scan without injection of contrast media within 4 to 8 hours for patients with the following characteristics :
- a retrograde amnesia of more than 30 minutes,
- a loss of consciousness or amnesia associated with:
- either a risk mechanism (pedestrian overturned by a motor vehicle, ejection of a vehicle, falling by more than one meter),
- or an age> 65 years,
- or coagulation disorders, including the use of platelet aggregation therapy. Patients who fall outside this definition are considered low risk of complication and should not benefit of imaging.
Data from the scientific literature show that an early brain CT-scan allows identification of post-traumatic lesions in this population. Nevertheless, organizational problems, including the availability of the imaging, radiation, and disruption of surveillance related to patient displacement, are limitations to this strategy. In contrast, the low cost-effectiveness of CT scan is often advocated in patients with mild traumatic brain injury. For example, in the Octopus study, 52 of 1316 patients who received CT scan after mild head trauma had an intracerebral lesion. Among these patients, 39 (3%) had intracerebral lesion related to trauma; for 13 (1%) patients, the link with the trauma was uncertain.
In fact, the search of alternatives for a safer, more conservative, more efficient practice, one of the objectives of which is to limit the undue use of cerebral scanning. Thus, many teams have been interested in the use of biological variables to guide the decision to use imagery.
Among candidate biomarkers, the S100B protein has been the subject of many evaluations which allow it to be used in current practice. Indeed, the increase of the S100B protein carried out within 3 hours following a mild head trauma makes it possible to identify the patients at risk of intracerebral lesion and to target the indications of imaging.
The purpose of the registry is to describe the use, interpretation and performance of the S100B protein in its use at bedside in emergency medicine.
- Conditions
- Mild Traumatic Brain Injury
- Being tested
- S100B protein dosage, Brain CT scan
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S100B protein dosageBiological
S100B protein dosage will be carried out, by a blood sample, on the earliest after admission and before 3th hour following brain injury S100B protein dosage will be left to the assessment of the emergency physician in charge of the patient
Brain CT scanOther
No injected brain CT-scan, regardless of the time between the brain injury and the arrival in the emergency unit. Realization of CT-scan will be left to the assessment of the emergency physician in charge of the patient
| Study group | Role | What they receive |
|---|---|---|
| Patients who had been tested for S100B protein | Not described Receives: Biological: S100B protein dosage | |
| Patients who have benefited from another strategy | Not described Receives: Other: Brain CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the number of brain CT-scan saved in patients who have been tested for S100B protein
Percentage (%)
Measured: 53 weeks
Secondary outcomes (3)
Comparison of supported patients with S100B protein assay or without S100B protein assay
Percentage (%)
Measured: 53 weeks
Intensive treatment comparison of the patients included in the centers that carried out an "intensive implementation" of the use of the S100B protein and those included in the centers that provided the S100B protein
Percentage (%)
Measured: 53 weeks
Quantification and evaluation of deviations to the algorithm
Percentage (%)
Measured: 53 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start14 May 2018
- Primary completion15 Jul 2021
- Study completion22 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 787 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Princesse Grace
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yann-Erick CLAESSENS, PU-PH, Study director, Centre Hospitalier Princesse GraceKarim TAZAROURTE, PU-PH, Study director, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313505
- Sponsor's protocol ID
- 16-09
- Other IDs
- 2016-A00901-50
- Acronym
- PROMETHEE
- Status last verified
- Jul 2021
- First submitted
- 13 Oct 2017
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROtein S100B for Mild Trauma of the HEad in Emergency Patients
- ClinicalTrials.gov ID
- NCT03313505
- Acronym / sponsor ID
- PROMETHEE / 16-09
- Conditions
- Mild Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 787 participants (actual)
- Lead sponsor
- Centre Hospitalier Princesse GraceUniversity, hospital or other
- Study start
- 14 May 2018 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 22 Jul 2021 (actual)
- First posted
- 18 Oct 2017 (actual)
- 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.
Brain injury is a frequent purpose for consultation in emergency services. Management of brain injury is time and resource consuming, combining clinical monitoring and imaging.
The stage prior to the management of the victims of brain injury is stratification of the severity, potential or proven.
Severe brain injury requires emergent brain CT-scan, ideally within one hour of the first medical contact. Patients requiring this strategy present with focused neurological deficit, Glasgow score <15 to 2 hours after the trauma, suspicion of open fracture of the skull or dish pan fracture, any signs of fracture of the skull base (hemotympanum, bilateral peri-orbital ecchymosis), otorrhea or rhinorrhea of cerebrospinal fluid, more than one episode of vomiting in adults, and posttraumatic convulsion. Patients benefiting from anticoagulant therapy are included in this category.
Victims of brain injury that do not fall into this category are considered less critical.
By definition, mild traumatic brain injury :
- a trauma of the cephalic extremity :
- whose Glasgow score (30 min after the trauma or during the consultation) is 13-15,
- associated with one or more of the following: confusion; disorientation; loss of consciousness of 30 min or less; post-traumatic amnesia of less than 24 hours; other transient neurological abnormalities (focal signs, epileptic seizures, non-surgical intracranial lesion).
Among these patients, some are considered at risk of developing intracerebral lesions. Nevertheless, it should be noted that the prevalence of hemorrhagic complications is radically different between patients with a Glasgow score of 13 and those with a score of 15. Thus, the recommendations suggest a brain scan without injection of contrast media within 4 to 8 hours for patients with the following characteristics :
- a retrograde amnesia of more than 30 minutes,
- a loss of consciousness or amnesia associated with:
- either a risk mechanism (pedestrian overturned by a motor vehicle, ejection of a vehicle, falling by more than one meter),
- or an age> 65 years,
- or coagulation disorders, including the use of platelet aggregation therapy. Patients who fall outside this definition are considered low risk of complication and should not benefit of imaging.
Data from the scientific literature show that an early brain CT-scan allows identification of post-traumatic lesions in this population. Nevertheless, organizational problems, including the availability of the imaging, radiation, and disruption of surveillance related to patient displacement, are limitations to this strategy. In contrast, the low cost-effectiveness of CT scan is often advocated in patients with mild traumatic brain injury. For example, in the Octopus study, 52 of 1316 patients who received CT scan after mild head trauma had an intracerebral lesion. Among these patients, 39 (3%) had intracerebral lesion related to trauma; for 13 (1%) patients, the link with the trauma was uncertain.
In fact, the search of alternatives for a safer, more conservative, more efficient practice, one of the objectives of which is to limit the undue use of cerebral scanning. Thus, many teams have been interested in the use of biological variables to guide the decision to use imagery.
Among candidate biomarkers, the S100B protein has been the subject of many evaluations which allow it to be used in current practice. Indeed, the increase of the S100B protein carried out within 3 hours following a mild head trauma makes it possible to identify the patients at risk of intracerebral lesion and to target the indications of imaging.
The purpose of the registry is to describe the use, interpretation and performance of the S100B protein in its use at bedside in emergency medicine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who had been tested for S100B protein | – | Biological: S100B protein dosage |
| Patients who have benefited from another strategy | – | Other: Brain CT scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the emergency unit with mild brain injury and meeting the inclusion criteria
Key inclusion criteria (10 listed)
- Adult Patients
- Victims of mild head trauma at risk of complication :
- retrograde amnesia of more than 30 minutes, or
- loss of consciousness or amnesia of the facts associated with:
- Admitted to the emergency department within three hours of the traumatic event.
Key exclusion criteria (4 listed)
- Refusal to participate at the study
- Patients with obstacle to 7 days follow up
- Pregnant women
- Patients not subject to an health insurance scheme in France or Monaco.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S100B protein dosageS100B protein dosage will be carried out, by a blood sample, on the earliest after admission and before 3th hour following brain injury S100B protein dosage will be left to the assessment of the emergency physician in charge of the patient | Biological | Patients who had been tested for S100B protein |
| Brain CT scanNo injected brain CT-scan, regardless of the time between the brain injury and the arrival in the emergency unit. Realization of CT-scan will be left to the assessment of the emergency physician in charge of the patient | Other | Patients who have benefited from another strategy |
Primary outcome
Evaluation of the number of brain CT-scan saved in patients who have been tested for S100B protein
Time frame: 53 weeks
Percentage (%)
3 secondary outcomes
Comparison of supported patients with S100B protein assay or without S100B protein assay
Time frame: 53 weeks
Intensive treatment comparison of the patients included in the centers that carried out an "intensive implementation" of the use of the S100B protein and those included in the centers that provided the S100B protein
Time frame: 53 weeks
Quantification and evaluation of deviations to the algorithm
Time frame: 53 weeks
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 29 Jul 2021.
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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.
Yann-Erick CLAESSENS, PU-PH study director
Centre Hospitalier Princesse Grace
Karim TAZAROURTE, PU-PH study director
Hospices Civils de Lyon
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Traumatic Brain Injury, run by Centre Hospitalier Princesse Grace at 15 sites in 2 countries.
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 10 inclusion and 4 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 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France, Monaco. 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?
Evaluation of the number of brain CT-scan saved in patients who have been tested for S100B protein (time frame: 53 weeks). 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 29 Jul 2021.