Analyzing early hormone changes in patients with traumatic brain injury

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

This study looks at how hormone levels change right after a traumatic brain injury to see if these changes could help us understand and treat hormone-related problems in patients.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: General Hospital of Ningxia Medical University (Academic / other)
• Locations: 1 site (Yinchuan, Ningxia)
• Trial ID: NCT06221215 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the neuroendocrine dysfunction that may occur after traumatic brain injury (TBI), particularly focusing on hormone changes related to the hypothalamic-pituitary-adrenal (HPA) axis in the early stages post-injury. By measuring early hormone levels in patients diagnosed with TBI, the study seeks to establish a clearer understanding of the relationship between craniocerebral trauma and hormone disorders. The findings could provide insights into the potential benefits of hormone replacement therapy for patients experiencing neuroendocrine disorders following TBI.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with moderate to severe craniocerebral injury.

Not a fit: Patients with severe visceral injuries, endocrine diseases, or those who have recently undergone immune or hormone therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved early detection and treatment strategies for hormone-related complications in TBI patients.

How similar studies have performed: While there is limited literature on this specific approach, the study addresses a significant gap in understanding neuroendocrine dysfunction after TBI, suggesting a novel area of investigation.

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.

Where this trial is running

Yinchuan, Ningxia

• The General Hospital of Ningxia Medical University — Yinchuan, Ningxia, China (Recruiting)

Study contacts

• Study coordinator: Zhanfeng Niu, Doctor

Conditions Brain Injury Traumatic Diffuse With Loss of Consciousness; Traumatic brain injury; Cerebral hemorrhage; hormone; trauma