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Long-term Outcome Related Prognostic Factor and Biomarkers of Major Trauma Database Analysis

2015年3月9日 更新者:National Taiwan University Hospital
The investigators were looking for resuscitation management, trauma mechanism, risk factors, and de novo biomarkers related to prognosis and long-term outcome for evaluating trauma patients besides injury severity score (ISS) guiding the traumatologist. The medicare resource could be utilized efficiently along with increasing in the survival and quality of lifer (QoL) in major trauma.

研究概览

地位

未知

详细说明

Severe traumatic injury occupied the sixth leading cause of death in Taiwan, especially in young adults. In 2013, there were accidental deaths in every 76 minutes. Not compared with the malignancy, heart disease, cerebrovascular disease, diabetes mellitus, or pneumonia Since 1995, Taiwan replaced a previous patchwork of separate social health insurance funds with one single-payer, National Health Insurance (NHI) scheme that is administered by an agency of the central government's Department of Health. NHI supported the cost of Critical Illness and Injury that numerous patients with major trauma were eligible for preference. However, the national medical cost of trauma care, especially in poly-trauma or major trauma were impressive: the adjusted national inpatient trauma yearly costs were estimated at $37,511,328,659 US dollars; the national insurance cost provided by Bureau of National Health Insurance, Department of Health for trauma was over $20,000,000,000 new Taiwan dollars till 1999 with increasing yearly.

Recently it flashed bulletins nationwide and overseas for catastrophes, such as aircraft accident, wrecks, or underground gas explosions. There was a stirring of interest in life support system for major trauma related rescue from dying. Death to trauma is caused by costly damages on scene, hemorrhage shock or trauma and massive transfusion related acute respiratory distress syndrome (ARDS). Extra-Corporeal Membrane Oxygenation (ECMO) can rescue life from severe cardiopulmonary failure, but coexisting complication as bleeding and coagulopathy restricting the utilization the use in trauma patients. Besides, there were more portable ECMO sets making a debut, especially for air transportation. It act now the medical transferral for trauma patients under ECMO support. The portable ECMO sets launched with possibility, accessibility, and convenience. The issue of life support system utilization, long-term outcome, and medical cost-effectiveness for major trauma patients was worth discussing no matter in National Taiwan University Hospital (NTUH) trauma database or National Health Insurance Research Database (NHIRD).

Immune system alteration was previously considered the mechanism of post-traumatic stress disorder (PTSD). Moreover, an externally experienced traumatic event induces downstream alterations in immune function by reducing methylation.

研究类型

观察性的

注册 (预期的)

500

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

      • Taipei City、台湾、100
        • 招聘中
        • National Taiwan University Hospital
        • 接触:

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

20年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

All major trauma (ISS>=16 ) patients sent to NTUH and initiated the trauma team, except children younger than 20 years old, pregnancy woman, breast feeding woman, and those forbidden legally.

描述

Inclusion criteria:

  • age ≧ 20
  • willing to join this study and sign the inform consent form by the patients or their contactable families
  • ISS score ≧ 16, or meet trauma blue or trauma red criteria
  • response to primary resuscitation
  • without uncontrolled or major (>1500mL) bleeding.

Exclusion criteria:

  • active malignancy before the event of major trauma
  • age <20, pregnancy woman, breast-feeding woman, or mental illness
  • uncontrolled bleeding with hemoglobin <7g/dL after treatment.

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

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Event related survival
大体时间:30 days
since major trauma event till trauma related death
30 days

次要结果测量

结果测量
措施说明
大体时间
Functional status
大体时间:12 months
Besides Rehabilitation Complexity Scale (RCS) and Functional Independence Measure (FIM) for traumatic brain injury patients, Glasgow Outcome Scale - Extended (GOS-E) and European Quality of Life Five Dimensions Questionnaire (EQ-5D) are used in concerning longer-term outcome indicators. There are currently no robust measures of patient experience for use in major trauma. Functional status after the major trauma event could be measured using non-clinical outcomes such as return to work, maintenance of education and societal dependency at post injury 3, 6, and 12 months.
12 months
over all survival
大体时间:2 years
since major trauma event till death
2 years

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。

调查人员

  • 首席研究员:Ting-Chun Kuo, M.D.、No.7, Chung San South Road, Taipei City 100, Taiwan (R.O.C.)

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

2015年2月1日

初级完成 (预期的)

2020年1月1日

研究完成 (预期的)

2020年1月1日

研究注册日期

首次提交

2015年2月6日

首先提交符合 QC 标准的

2015年2月19日

首次发布 (估计)

2015年2月20日

研究记录更新

最后更新发布 (估计)

2015年3月17日

上次提交的符合 QC 标准的更新

2015年3月9日

最后验证

2015年3月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 201410060RINA

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.

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