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Serum S100B Protein Assay in Mild Head Injury (TCLAS-100B)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03345602
Recruitment Status : Unknown
Verified November 2017 by University Hospital, Caen.
Recruitment status was:  Not yet recruiting
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Information provided by (Responsible Party):
University Hospital, Caen

Brief Summary:

Head injuries are a major public health issue, with an estimated annual incidence in Europe of 262 per 100,000 population. Light head injury (SCI), defined by a Glasgow score between 13 and 15, constitutes the majority (71% to 98%) of head injury cases. Despite a generally good prognosis, patients with TCL have a low but real risk of brain damage, whose prevalence is estimated at 5%. Cerebral computed tomography (CT) because of its high sensitivity for the detection of posttraumatic intracranial lesions (LIC), is currently considered the gold standard for the diagnosis of these lesions in patients considered at risk after clinical evaluation. The number of cTCTs performed is high with no lesion in more than 90% of cases. The S100B protein, a marker of brain tissue damage, is reported to reliably exclude the presence of brain lesions in adults as well as antiaggregants. These numerous studies show that its serum assay in combination with the clinical decision algorithms allows, thanks to a sensitivity close to 100% for brain lesions, to reduce the number of CTMc currently prescribed by approximately 30%, and therefore to decrease unnecessary exposure to radiation. Although there is no study on the subject, a gain on the duration of care in emergencies can be expected as well as a reduction on the cost of care by a dosage price three times less higher than the TDMc. Expert opinion for the use of this assay in the management of moderate-risk TCL at threshold ≤ 0.10 μg / L in 3h post-TC to ensure sensitivity of 100%, was published in 2014 in the Annales Françaises de Médecine d'Urgence.

The use of anticoagulants has continued to increase in recent years. In 2013, it is estimated that 3.12 million patients received at least one anticoagulant in France. Currently, the international and French recommendations indicate the achievement of cTCT in anticoagulated TCL because it is an independent risk factor for cerebral injury and is therefore considered to be a high risk TCL. LIC. The hypothesis of this study is that the S100B protein assay could also exclude the presence of brain lesion after TCL under anticoagulation in adults

Condition or disease Intervention/treatment
Light Head Injury Diagnostic Test: serum S100B protein assay measurement

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Serum S100B Protein Assay in the Management of Mild Head Injury Under Anticoagulation
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Head Injuries

Intervention Details:
  • Diagnostic Test: serum S100B protein assay measurement
    serum S100B protein assay measurement within the 3 hours after head trauma

Primary Outcome Measures :
  1. S100B protein serum concentration [ Time Frame: baseline (maximum 3 hours after head trauma) ]
    The main objective of this study is to evaluate whether a negative serum assay of S100B protein (≤ 0.10 μg / L) within 3 hours after head trauma

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
  • Cranial Trauma having induced a Glasgow <13
  • Presence of a high risk factor to perform a brain scan (formal indication of cTCT): Focused neurological deficit, Glasgow score <15 at 2 hr, suspicion of open skull fracture or embarrassment, all Sign of fracture of the base of the skull (hemotympanum, bilateral periorbital ecchymosis), otorrhea or rhinorrhea of CSF, convulsion post traumatic.
  • Cranial Trauma time unknown
  • Fuzzy anamnesis
  • Traumatized severe / polytraumatized (victim of a violent trauma, according to the kinetic criteria of Vittel, whatever are the apparent lesions and / or 2 lesions or more of which at least one threatens the vital prognosis)
  • Refusal to participate
  • Refusal to perform a TDMc
  • Congenital or acquired coagulopathy
  • Decision not to carry out a TDMc
  • Active melanoma

Inclusion Criteria:

  • Major patient
  • Emergency department patient with mild head trauma (13 ≤ Glasgow score ≤ 15)
  • Affiliated to the social security scheme
  • Patient having been informed about the study and do not disagree to participate
  • Patient on anticoagulant therapy (enteral or parenteral route)

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03345602

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Caen University Hospital
Caen, France, 14000
Contact: Alexandre GUGNE, MD    0231063404 ext +33   
Sponsors and Collaborators
University Hospital, Caen
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Responsible Party: University Hospital, Caen Identifier: NCT03345602    
Other Study ID Numbers: 17-091
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Craniocerebral Trauma
Wounds and Injuries
Trauma, Nervous System
Nervous System Diseases