Light Head Injury Clinical Trial
— TCLAS-100BOfficial title:
Evaluation of the Serum S100B Protein Assay in the Management of Mild Head Injury Under Anticoagulation
| Verified date | November 2017 |
| Source | University Hospital, Caen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Not yet recruiting |
| Enrollment | 400 |
| Est. completion date | July 1, 2020 |
| Est. primary completion date | March 1, 2020 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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: |
| Country | Name | City | State |
|---|---|---|---|
| France | Caen University Hospital | Caen |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Caen |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | S100B protein serum concentration | 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 | baseline (maximum 3 hours after head trauma) |