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

NCT06221215 | Unknown

• 1 other identifier: GHNingxia
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injury Traumatic Diffuse With Loss of Consciousness

Keywords

Traumatic brain injury; Cerebral hemorrhage; hormone; trauma

Outcome Measures

Primary Outcomes (6)

• 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.

Study Arms (2)

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

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.

Interventions

trauma PROCEDURE

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.

Traumatic brain injury Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Qualified inpatients hospitalized in our hospital

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (1)

The General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Cerebral Hemorrhage; Wounds and Injuries

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhanfeng Niu, Doctor

  General Hospital of Ningxia Medical University

  STUDY DIRECTOR

Central Study Contacts

Zhanfeng Niu, Doctor

CONTACT

+8613995297581; niuzfeng228626@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2023
• First Posted: January 24, 2024
• Study Start: October 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 24, 2024

Record last verified: 2024-01

Locations

CN (1)