Biomarkers in Prehospital Prediction of Need for Neurosurgical Observation or Intervention in TBI Patients (PreTBI II)
2019年4月23日 更新者：University of Aarhus
S100B and Glial Fibrillary Acidic Protein (GFAP) in Prehospital Prediction of Need for Neurosurgical Observation or Intervention in Patients Suffering Moderate Traumatic Brain Injury (TBI)
The PreTBI II study aims to investigate the diagnostic potential of prehospital S100B and GFAP measurements in prediction of need for neurosurgical observation and/or intervention in moderate TBI patients, to rule-in high-risk patients. Ultimately to select patients who will benefit from neuro surgical expertise in specialized departments and thereby possibly better patient outcome. Hopefully also minimize treatment delay, secure optimal resource consumption and streamline patient courses by predicting the presence of neurotrauma.
Hypotheses:
- A prehospital serum S100B level > 0,10 microgram/L and expectedly above a certain and currently unknown cut-off value indicates the need for neurosurgical observation and/or intervention in moderate TBI patients.
- A prehospital serum GFAP level above a certain and currently unknown cut-off value can significantly predict a need for urgent neurosurgical observation and/or intervention in moderate TBI patients.
- Biomarker dynamics between prehospital and in-hospital biomarker values of S100B and GFAP can significantly predict a need for urgent neurosurgical observation and/or intervention.
- Biomarker dynamics between prehospital and in-hospital biomarker values of S100B and GFAP can significantly predict hospital course and outcome of patients with moderate TBI.
研究概览
研究类型
观察性的
注册 (实际的)
22
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Aarhus N、丹麦、8200
- Prehospital Emergency Medical Services, Central Denmark Region
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 100年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
All adult patients (≥18 years) suffering isolated head trauma and receiving an ambulance or anaesthetist-staffed critical care team dispatched by the Prehospital Emergency Medical Services (EMS) in the Central Denmark Region.
描述
Inclusion Criteria:
- Patients presenting with Glasgow Coma Score (GCS) GCS 9-13 suffering relevant trauma and displaying relevant clinical indices compatible with TBI as evaluated by EMS staff. Patients are considered incompetent due to on-going alteration of mental state.
Exclusion Criteria:
- Patients <18 years, GCS <9, >6 hours elapsed after trauma, unknown time of trauma, multi trauma, known dementia, chronic psychosis or active central nervous system (CNS) pathology.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Moderate TBI patients
GCS 9-13
|
外伤患者在转运过程中常规插入的外周静脉导管采血
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Sensitivity of se-S100B in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
大体时间：in relation to event within 7 days of trauma
|
in relation to event within 7 days of trauma
|
|
Specificity of se-S100B in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
大体时间：in relation to event within 7 days of trauma
|
in relation to event within 7 days of trauma
|
|
Positive predictive value of se-S100B in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
大体时间：in relation to event within 7 days of trauma
|
in relation to event within 7 days of trauma
|
|
Negative predictive value of se-S100B in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
大体时间：in relation to event within 7 days of trauma
|
in relation to event within 7 days of trauma
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Sensitivity of se-GFAP in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
大体时间：in relation to event within 7 days of trauma
|
in relation to event within 7 days of trauma
|
|
Specificity of se-GFAP in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
大体时间：in relation to event within 7 days of trauma
|
in relation to event within 7 days of trauma
|
|
Positive predictive value of se-GFAP in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
大体时间：in relation to event within 7 days of trauma
|
in relation to event within 7 days of trauma
|
|
Negative predictive value of se-GFAP in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
大体时间：in relation to event within 7 days of trauma
|
in relation to event within 7 days of trauma
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Se-S100B、se-GFAP 和 se-NSE 值的院前和院内组合与通过“有利的神经学结果”的是/否问题测量的二元结果相关的生物标志物动态选择有利/不利
大体时间：与创伤后 1 年内的事件有关
|
与创伤后 1 年内的事件有关
|
|
|
Sensitivity of combined se-S100B and se-GFAP in relation to a binary outcome measured by by a yes/no question of "immediate treatment <24h/deferred treatment <24h" pick immediate/deferred
大体时间：in relation to event within 24 hours of trauma
|
in relation to event within 24 hours of trauma
|
|
|
Specificity of combined se-S100B and se-GFAP in relation to a binary outcome measured by by a yes/no question of "immediate treatment <24h/deferred treatment <24h" pick immediate/deferred
大体时间：in relation to event within 24 hours of trauma
|
in relation to event within 24 hours of trauma
|
|
|
Positive predictive value of combined se-S100B and se-GFAP in relation to a binary outcome measured by by a yes/no question of "immediate treatment <24h/deferred treatment <24h" pick immediate/deferred
大体时间：in relation to event within 24 hours of trauma
|
in relation to event within 24 hours of trauma
|
|
|
Negative predictive value of combined se-S100B and se-GFAP in relation to a binary outcome measured by by a yes/no question of "immediate treatment <24h/deferred treatment <24h" pick immediate/deferred
大体时间：in relation to event within 24 hours of trauma
|
in relation to event within 24 hours of trauma
|
|
|
Biomarker dynamics between prehospital and in-hospital se-S100B values in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
大体时间：in relation to event within 24 hours of trauma
|
in relation to event within 24 hours of trauma
|
|
|
Biomarker dynamics between prehospital and in-hospital se-GFAP values in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no
大体时间：in relation to event within 24 hours of trauma
|
in relation to event within 24 hours of trauma
|
|
|
Biomarker dynamics between prehospital and in-hospital se-S100B values in relation to a binary outcome measured by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
大体时间：in relation to event within 1 year of trauma
|
Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)
|
in relation to event within 1 year of trauma
|
|
Biomarker dynamics between prehospital and in-hospital se-GFAP values in relation to a binary outcome measured by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable
大体时间：in relation to event within 1 year of trauma
|
Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)
|
in relation to event within 1 year of trauma
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年2月15日
初级完成 (实际的)
2019年2月1日
研究完成 (实际的)
2019年2月1日
研究注册日期
首次提交
2016年11月21日
首先提交符合 QC 标准的
2017年1月19日
首次发布 (估计)
2017年1月23日
研究记录更新
最后更新发布 (实际的)
2019年4月24日
上次提交的符合 QC 标准的更新
2019年4月23日
最后验证
2018年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.