Prevalence of adult growth hormone deficiency after traumatic brain injury

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2300072902

Enrollment

Unknown

Registered

2023-06-27

Start date

2022-06-15

Completion date

Unknown

Last updated

2023-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

traumatic brain injury

Interventions

1-3months after traumatic brain injury:none

4-6months after traumatic brain injury:none

7-12months after traumatic brain injury:none

13-24months after traumatic brain injury:none

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. aged 18-65 years; 2. when the subject signed the informed consent and entered the screening period, the vital signs and neurological symptoms and signs were stable for more than 1 month from the time of occurrence of craniocerebral trauma, and the duration of TBI was less than 24 months; 3. the subject is willing and able to cooperate to complete the scheduled visit, treatment plan, laboratory examination and other test procedures, and sign the written informed consent.

Exclusion criteria

Exclusion criteria: 1. disturbance of consciousness and unstable vital signs. 2. pregnancy: for women with childbearing potential, pregnancy urine test is required to be negative. 3. renal insufficiency (serum creatinine greater than 3.0 mg/dl) or end-stage renal disease. Renal replacement therapy is needed. 4. systolic blood pressure < 90mmHg and / or diastolic blood pressure < 50mmhg. 5. clinically significant ECG abnormalities, and the investigator believes that it is not suitable to enter this study. 6. Do not suitable for venipuncture. 7. congestive heart failure, New York Heart Association (NYHA) class III or IV. 8. seizures. 9. Who have participated in clinical trials of any drug or medical device within 3 months before screening (only signed the informed consent, except those who have not received any drug or device intervention). 10. Who have used growth hormone treatment in recent 1 year. 11. other reasons that the researcher believes need to be excluded.

Design outcomes

Primary

Measure	Time frame
Prevalence;	—

Secondary

Measure	Time frame
Mini-mental State Examination;Modified Barthel Index Rating Scale;PHQ-9 Depression Screening Scale;WHOQOL BREF;Disability Rating Scale;Fatigue Severity Scale;Helsinki CT score;	—

Countries

China

Contacts

Public ContactZhang Hao

China Rehabilitation Research Center

crrczh2020@163.com+86 137 0135 6685

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 27, 2026