PROtein S100B for Mild Trauma of the HEad in Emergency Patients

NCT03313505 | Completed

• 2 other identifiers: 16-092016-A00901-50
• Study Type: observational
• Target: 787
• Locations: 2 countries
• Sites: 15

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Evaluation of the number of brain CT-scan saved in patients who have been tested for S100B protein

  Percentage (%)

  53 weeks

Secondary Outcomes (3)

• Comparison of supported patients with S100B protein assay or without S100B protein assay

  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

  53 weeks

• Quantification and evaluation of deviations to the algorithm

  53 weeks

Study Arms (2)

Patients who had been tested for S100B protein

Biological: S100B protein dosage

Patients who have benefited from another strategy

Other: Brain CT scan

Interventions

S100B protein dosage BIOLOGICAL

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

Patients who had been tested for S100B protein

Brain CT scan OTHER

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

Patients who have benefited from another strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients admitted to the emergency unit with mild brain injury and meeting the inclusion criteria

You may qualify if:

• 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),
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Princesse Grace: lead

Study Sites (15)

Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

AP-HP Centre Hospitalier Universitaire Henri-Mondor

Créteil, 94000, France

Location

Hospices Civils de Lyon - Pôle Est

Lyon, 69002, France

Location

AP-HM La Timone

Marseille, 13915, France

Location

Centre Hospitalier de Metz-Thionville

Metz, 57085, France

Location

Centre Hospitalier Universitaire de Nice, Hôpital Pasteur

Nice, 06000, France

Location

Centre Hospitalier Universitaire de Nîmes - Hôpital Carémeau

Nîmes, 30029, France

Location

AP-HP Nord Lariboisière

Paris, 75010, France

Location

AP-HP Sud Pitié-Salpêtrière

Paris, 75013, France

Location

Centre Hospitalier Universitaire de Poitiers

Poitiers, 86000, France

Location

Hôpital Charles Nicolle

Rouen, 76031, France

Location

CHU de Strasbourg

Strasbourg, France

Location

HIA Sainte Anne

Toulon, 83800, France

Location

Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan

Toulouse, 31059, France

Location

Centre Hospitalier Princesse Grace

Monaco, 98000, Monaco

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Yann-Erick CLAESSENS, PU-PH

  Centre Hospitalier Princesse Grace

  STUDY DIRECTOR

• Karim TAZAROURTE, PU-PH

  Hospices Civils de Lyon

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: October 18, 2017
• Study Start: May 14, 2018
• Primary Completion: July 15, 2021
• Study Completion: July 22, 2021
• Last Updated: July 29, 2021

Record last verified: 2021-07

Locations

FR (14); MO (1)