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临床试验/NCT03345602
NCT03345602Unknown不适用

Evaluation of the Serum S100B Protein Assay in the Management of Mild Head Injury Under Anticoagulation

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
试验地点
1
主要终点
S100B protein serum concentration

研究概览

简要总结

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 未提供

结局指标

主要结局

S100B protein serum concentration

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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