Clinical trial NCT06221215: Clinical Analysis of Early Hormones Between Patients With Traumatic Brain Injury and Cerebral Hemorrhage
Official title: Clinical Analysis of the Hormone Between Patients With Moderate and Severe Traumatic Brain Injury and Cerebral Hemorrhage
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Injury Traumatic Diffuse With Loss of Consciousness
Keywords: Traumatic brain injury
Cerebral hemorrhage
hormone
trauma
Lead sponsor: General Hospital of Ningxia Medical University
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Qualified inpatients hospitalized in our hospital

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change of GH
timeFrame: 1st, 7th and 14th day.
measure: Change of pituitary prolactin
timeFrame: 1st, 7th and 14th day.
measure: Change of ACTH
timeFrame: 1st, 7th and 14th day.
measure: Change of cortisol
timeFrame: 1st, 7th and 14th day.
measure: Change of FSH
timeFrame: 1st, 7th and 14th day.
measure: Change of thyroid hormone
timeFrame: 1st, 7th and 14th day.
Secondary outcomes:
Other outcomes:
Locations:
city: Yinchuan
country: China
facility: The General Hospital of Ningxia Medical University
state: Ningxia
Study officials:
affiliation: General Hospital of Ningxia Medical University
name: Zhanfeng Niu, Doctor
role: STUDY_DIRECTOR
References: