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NCT ID: NCT03345602 Not yet recruiting - Light Head Injury Clinical Trials

Serum S100B Protein Assay in Mild Head Injury

TCLAS-100B
Start date: March 1, 2018
Phase: N/A
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

NCT ID: NCT01470040 Not yet recruiting - Clinical trials for Traumatic Brain Injury

Does Discontinuation of Aspirin Treatment Following Head Trauma Decrease the Incidence of Chronic Subdural Hematoma?

Start date: February 2012
Phase: Phase 4
Study type: Interventional

Anti-aggregation therapy, including treatment with low-dose aspirin (LDA) is an established risk factor for intracranial hemorrhage, including chronic subdural hematoma (CSDH); however evidence guiding the decision to continue or discontinue LDA in patients who have sustained mild head trauma with no sign of injury on CT is lacking. The investigators aim to assess whether continued aspirin treatment increases the risk of CSDH in mild head trauma patients 50 years and older who present with negative head CT. The investigators further aim to use the initial findings to refine the study design, with the goal of performing a larger, multi-institutional study in the future. Over a 12-month period, approximately 100 patients ≥50 years of age on LDA prophylaxis presenting to Hadassah's Emergency Department after sustaining mild head injury, will be examined by the neurosurgeon on call. Those who have no sign of intracranial hemorrhage at clinical or CT examination, and who meet inclusion / exclusion criteria, will be invited to participate in a randomized study. Informed consent will be obtained. Patients will be remotely randomized for continuation or cessation of LDA treatment. Follow-up CT and clinical examination will be performed 3-5 weeks after trauma. The two-proportions test will be used to assess whether there is a statistically significant difference in the rate of CSDH in patients randomized to cessation of LDA therapy and those randomized to continuation of LDA. Relationships between the explanatory the dependent variables will be explored with classical parametric and nonparametric statistical methods, including multivariate analysis, logistic regression, the two proportions test, and the independence test. Several measures of association/correlation between pairs of variables will be analyzed as well. The investigators hypothesize that continuation of LDA will not be associated with increased risk for chronic subdural hematoma, and that cessation of treatment will not be associated with a decrease in chronic subdural hematoma. The investigators further hypothesize that cessation of LDA for this period will not be associated with increased risk for clinically significant cerebrovascular, cardiovascular, thrombotic, of embolic event.