NCT03345602: TCLAS-100B

Serum S100B Protein Assay in Mild Head Injury

Status unknown Last updated 17 November 2017

What this trial tests

trial testing serum S100B protein assay measurement in Light Head Injury in 400 participants. Status unknown.

Timeline

1 March 2018

Primary endpoint
1 March 2020

1 July 2020

Quick facts

Lead sponsor	University Hospital, Caen
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	400
Start date	1 March 2018
Primary completion	1 March 2020
Estimated completion	1 July 2020
Sites	1 location across France

Drugs / interventions tested

• serum S100B protein assay measurement

Conditions studied

• Light Head Injury — all drugs for Light Head Injury →

Sponsor

University Hospital, Caen

Who can join

18 and older, any sex, with Light Head Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.