Brain Injury Traumatic Diffuse With Loss of ConsciousnessNCT06221215
Clinical Analysis of Early Hormones Between Patients With Traumatic Brain Injury and Cerebral Hemorrhage
An observational study of Brain Injury Traumatic Diffuse With Loss of Consciousness, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brain Injury Traumatic Diffuse With Loss of Consciousness
- What is being tested?
- trauma
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 31 Dec 2024
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Qualified inpatients hospitalized in our hospital
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
Zhanfeng Niu, Doctor, 13995297581, niuzfeng228626@163.com
About this study
Official title: 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.
- Being tested
- trauma
- Keywords
- Traumatic brain injury, Cerebral hemorrhage, hormone, trauma
- Medical subject headings
- Brain Injuries, Traumatic, Cerebral Hemorrhage, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traumaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of GH
The levels of related hormones (growth hormone) were measured in patients with TBI.
Measured: 1st, 7th and 14th day.
Change of pituitary prolactin
The levels of related hormones (pituitary prolactin) were measured in patients with TBI.
Measured: 1st, 7th and 14th day.
Change of ACTH
The levels of related hormones ( ACTH) were measured in patients with TBI.
Measured: 1st, 7th and 14th day.
Change of cortisol
The levels of related hormones (cortisol) were measured in patients with TBI.
Measured: 1st, 7th and 14th day.
Change of FSH
The levels of related hormones (FSH) were measured in patients with TBI.
Measured: 1st, 7th and 14th day.
Change of thyroid hormone
The levels of related hormones (thyroid hormone) were measured in patients with TBI.
Measured: 1st, 7th and 14th day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Oct 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injury Traumatic Diffuse With Loss of ConsciousnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhanfeng Niu, Doctor, Study director, General Hospital of Ningxia Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221215
- Sponsor's protocol ID
- GHNingxia
- Status last verified
- Jan 2024
- First submitted
- 30 Dec 2023
- Last updated
- 24 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Analysis of the Hormone Between Patients With Moderate and Severe Traumatic Brain Injury and Cerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT06221215
- Acronym / sponsor ID
- GHNingxia
- Keywords
- Traumatic brain injury, Cerebral hemorrhage, hormone, trauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traumatic brain injury Group | – | Procedure: traumaThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Qualified inpatients hospitalized in our hospital
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| traumaThe 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. | Procedure or surgery | Traumatic brain injury Group |
Primary outcome
Change of GH
Time frame: 1st, 7th and 14th day.
The levels of related hormones (growth hormone) were measured in patients with TBI.
Change of pituitary prolactin
Time frame: 1st, 7th and 14th day.
The levels of related hormones (pituitary prolactin) were measured in patients with TBI.
Change of ACTH
Time frame: 1st, 7th and 14th day.
The levels of related hormones ( ACTH) were measured in patients with TBI.
Change of cortisol
Time frame: 1st, 7th and 14th day.
The levels of related hormones (cortisol) were measured in patients with TBI.
Change of FSH
Time frame: 1st, 7th and 14th day.
The levels of related hormones (FSH) were measured in patients with TBI.
Change of thyroid hormone
Time frame: 1st, 7th and 14th day.
The levels of related hormones (thyroid hormone) were measured in patients with TBI.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhanfeng Niu, Doctor study director
General Hospital of Ningxia Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injury Traumatic Diffuse With Loss of Consciousness, run by General Hospital of Ningxia Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhanfeng Niu, Doctor (+8613995297581, niuzfeng228626@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of GH (time frame: 1st, 7th and 14th day.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.