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临床试验/NCT03128658
NCT03128658已完成不适用

Trauma Induced Coagulopathy and Inflammation

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年2月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
Change in Thromboelastography parameters T0 -T3

研究概览

简要总结

While a number of factors are known to be associated with the development of trauma induced coagulopathy (TIC), inflammation, and multi-organ failure, we currently cannot predict which patients are at risk for developing these life threatening conditions with any certainty. In this prospective observational study, we will investigate the many factors that contribute to the development of trauma induced coagulopathy, post injury inflammation and the development of organ dysfunction in order to develop a multi scale computational algorithm of clinical prediction. Using a convenience sample technique, demographic data, physiologic data, blood samples and clinical variables will be collected over 5 days following traumatic injury. A computational model will be used to predict the development of TIC and multi-organ failure.

详细描述

A prospective, observational, convenience sample of trauma patients 18 years old or older who present to the trauma bay as a trauma alert will be included after evaluation by the on-call trauma surgeon and research assistant. Minimally injured patients will be compared to those with a systolic blood pressure of 90 mmHg or less, the need for blood product transfusion within 1 hour of admission, and/or an ISS (injury severity score) of greater than or equal to 15. Demographic data including past medical/medication history as well as clinical data including continuous vital signs will be recorded. If eligibility criteria are met, the research blood samples will be drawn at the same time as routine clinical samples. Blood samples (approximately 15 ml) will be taken on admission, 3hr, 6hrs, 12hrs, 24 hrs, 48 hrs, and 5 days post admission. Vital signs, number of blood transfusions, volume of crystalloid, administration of medications, and the values of routine laboratories will be monitored continuously for 24 hours, and then cumulatively for up to 5 days. After the last blood draw, we will be following the patient's outcome for up to 30 days. If patients are discharged or die prior to completing the 5 days of blood samples, additional samples and/or clinic appointments for the purpose of research will not be obtained. A computational algorithm will be used to predict the development of trauma induced coagulopathy, inflammation and multi-organ failure.

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

  • Injured patients presenting to the trauma bay with a trauma alert activation (highest level of activation)
  • Age 18 years old or more

排除标准

  • Transfer duration to trauma service exceeding 6 hours.
  • Known pregnancy

结局指标

主要结局

Change in Thromboelastography parameters T0 -T3

时间窗: Between time of admission (T0) and 3 hours (T3)

Variables: Reaction time (R value), the K value, the angle and the maximum amplitude (MA)

Change in Thromboelastography parameters T24 - T48

时间窗: Between 24 hours (T24) and 48 hours (T48)

Variables: Reaction time (R value), the K value, the angle and the maximum amplitude (MA)

Change in Thromboelastography parameters T6 -T12

时间窗: Between 6 hours (T6) and 12 hours (T12)

Variables: Reaction time (R value), the K value, the angle and the maximum amplitude (MA)

Change in Thromboelastography parameters T12 - T24

时间窗: Between 12 hours (T12) and 24 hours (T24)

Variables: Reaction time (R value), the K value, the angle and the maximum amplitude (MA)

Change in Thromboelastography parameters T48 - T120

时间窗: Between 48 hours (T48) and 120 hours (T120)

Variables: Reaction time (R value), the K value, the angle and the maximum amplitude (MA)

Change in Thromboelastography parameters T3 -T6

时间窗: Between 3 hours (T3) and 6 hours (T6)

Variables: Reaction time (R value), the K value, the angle and the maximum amplitude (MA)

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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