AzTrials
AzTrials

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.

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

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

Other trials in France

Monaco1 site
  • Centre Hospitalier Princesse Grace

    Monaco, 98000

Other trials in Monaco

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.

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 groups in NCT03313505
Study groupRoleWhat they receive
Patients who had been tested for S100B proteinNot described
Receives: Biological: S100B protein dosage
Patients who have benefited from another strategyNot described
Receives: Other: Brain CT scan

What is being measured

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

  1. 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)
  1. Comparison of supported patients with S100B protein assay or without S100B protein assay

    Percentage (%)

    Measured: 53 weeks

  2. 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

  3. 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.

  1. First posted18 Oct 2017
  2. Study start14 May 2018
  3. Primary completion15 Jul 2021
  4. Study completion22 Jul 2021

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
Prospective
Enrolment
787 participants (actual)
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

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.

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