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临床试验/NCT06221215
NCT06221215招募中不适用

Clinical Analysis of the Hormone Between Patients With Moderate and Severe Traumatic Brain Injury and Cerebral Hemorrhage

General Hospital of Ningxia Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Change of GH

研究概览

简要总结

Our understanding of neurosecretory dysfunction after TBI is still insufficient, and the number of patients with neuroendocrine dysfunction caused by craniocerebral trauma may be underestimated, especially the neuroendocrine changes related to HPA axis in the early stage after craniocerebral trauma. Moreover, there are few and fragmentary literature data on the benefits of hormone replacement therapy in patients with neuroendocrine disorders after traumatic brain injury. This requires more studies to further determine the characteristics of pituitary function or hormone disorders in the early stage after traumatic brain injury, which makes it necessary for us to further study the neuroendocrine dysfunction (hormone disorder) in the early stage after craniocerebral injury. To explore the relationship between craniocerebral injury and early hormone disorder by measuring the changes of early hormone levels in patients with TBI is of great significance for the early detection of related complications after craniocerebral injury and the evaluation of the prognosis of patients with craniocerebral injury, and can provide a new diagnosis and treatment plan for early intervention of related complications after TBI.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years old.
  • The patient was clearly diagnosed as craniocerebral injury.
  • The Glasgow score on admission was 3-12 (moderate and severe).
  • It has complete preclinical data.

排除标准

  • Complicated with other severe visceral injuries or severe systemic fractures.
  • Suffered from craniocerebral tumors, endocrine diseases, cardiovascular diseases, depression, sleep and mental disorders.
  • In the past month, there are people who receive immune and hormone therapy.
  • Women during pregnancy and lactation.
  • Where there is a logical or common sense error in the data entered.
  • The lack of too much clinical data related to this study.

结局指标

主要结局

Change of GH

时间窗: 1st, 7th and 14th day.

The levels of related hormones (growth hormone) were measured in patients with TBI.

Change of cortisol

时间窗: 1st, 7th and 14th day.

The levels of related hormones (cortisol) were measured in patients with TBI.

Change of thyroid hormone

时间窗: 1st, 7th and 14th day.

The levels of related hormones (thyroid hormone) were measured in patients with TBI.

Change of FSH

时间窗: 1st, 7th and 14th day.

The levels of related hormones (FSH) were measured in patients with TBI.

Change of pituitary prolactin

时间窗: 1st, 7th and 14th day.

The levels of related hormones (pituitary prolactin) were measured in patients with TBI.

Change of ACTH

时间窗: 1st, 7th and 14th day.

The levels of related hormones ( ACTH) were measured in patients with TBI.

次要结局

未报告次要终点

研究者

发起方
General Hospital of Ningxia Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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