Clinical Analysis of Early Hormones Between Patients With Traumatic Brain Injury and Cerebral Hemorrhage

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

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Injury Traumatic Diffuse With Loss of Consciousness
• Intervention / Treatment: Procedure: trauma

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Zhanfeng Niu, Doctor; Phone Number: +8613995297581; Email: niuzfeng228626@163.com

Study Locations

• China
  • Ningxia
    • Yinchuan, Ningxia, China, 750004
      • Recruiting
      • The General Hospital of Ningxia Medical University
      • Contact: Zhanfeng Niu, Doctor; Phone Number: 13995297581; Email: niuzfeng228626@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Qualified inpatients hospitalized in our hospital

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Traumatic brain injury Group; The levels of related hormones (growth hormone, pituitary prolactin, ACTH, cortisol, FSH, thyroid hormone, etc.) were measured in patients with traumatic brain injury on the 1st, 7th and 14th day.	Procedure: trauma; The main purpose of this study is to observe whether the early hormone changes and trends in the two groups of patients with or without trauma.
Spontaneous cerebral hemorrhage roup; The levels of related hormones (growth hormone, pituitary prolactin, ACTH, cortisol, FSH, thyroid hormone, etc.) were measured in patients with spontaneous craniocerebral injury on the 1st, 7th and 14th day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of GH	The levels of related hormones (growth hormone) were measured in patients with TBI.	1st, 7th and 14th day.
Change of pituitary prolactin	The levels of related hormones (pituitary prolactin) were measured in patients with TBI.	1st, 7th and 14th day.
Change of ACTH	The levels of related hormones ( ACTH) were measured in patients with TBI.	1st, 7th and 14th day.
Change of cortisol	The levels of related hormones (cortisol) were measured in patients with TBI.	1st, 7th and 14th day.
Change of FSH	The levels of related hormones (FSH) were measured in patients with TBI.	1st, 7th and 14th day.
Change of thyroid hormone	The levels of related hormones (thyroid hormone) were measured in patients with TBI.	1st, 7th and 14th day.

Collaborators and Investigators

• Sponsor: General Hospital of Ningxia Medical University
• Investigators: Study Director: Zhanfeng Niu, Doctor, General Hospital of Ningxia Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 30, 2023
• First Submitted That Met QC Criteria: January 14, 2024
• First Posted (Estimated): January 24, 2024

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 14, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: trauma; Traumatic brain injury; hormone; Cerebral hemorrhage
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Craniocerebral Trauma; Trauma, Nervous System; Consciousness Disorders; Intracranial Hemorrhages; Brain Injuries; Wounds and Injuries; Hemorrhage; Brain Injuries, Traumatic; Cerebral Hemorrhage; Unconsciousness
• Other Study ID Numbers: GHNingxia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No