A study to investigate the prevalence of pituitary gland dysfunction and it's risk factors following traumatic brain injuries (TBI)

Pituitary gland deficiencies after traumatic brain injury: An Outcomes and Prevalence Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN71291784

Enrollment

100

Registered

2017-09-14

Start date

2017-12-01

Completion date

Unknown

Last updated

2021-06-07

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

Conditions

Traumatic brain injury Nervous System Diseases Traumatic brain injury

Interventions

After informed consent, recruited participants have blood tests to assess the function of their brain. These tests are all performed between 8am and 10am and the patients have to be 'fasted' (nothing

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Primary traumatic Brain Injury (TBI) including multi trauma 2. Patients aged 17 years at the time of TBI 3. Informed consent obtained from participant

Exclusion criteria

Exclusion criteria: 1. Patients with a pre-existing endocrine diagnosis 2. Morbidly obese patients with BMI > 35 3. Unlikely to survive for the next 24 hours in the opinion of the Intensive care or Neurosurgical team treating the patient 4. Patients with known epilepsy 5. Patients on medications that are known to affect the hypothalamic-pituitary axis 6. Patients who are not able to consent

Design outcomes

Primary

Measure	Time frame
Prevalence of post TBI pituitary gland dysfunction (PTPD) is measured with pituitary function test (baseline measurements of serum thyroid stimulating hormone, free T4, testosterone, IGF-1 and cortisol) acutely (within 7 days), sub-acutely (within one month) and long-term (up to 6 months and up to 12 months) after TBI. Also a short synacthen test and GHRH + Arginine tests will be performed in the sub-acutely (within one month) and long-term (6 month and 12 months).	—

Measure

Time frame

Prevalence of post TBI pituitary gland dysfunction (PTPD) is measured with pituitary function test (baseline measurements of serum thyroid stimulating hormone, free T4, testosterone, IGF-1 and cortisol) acutely (within 7 days), sub-acutely (within one month) and long-term (up to 6 months and up to 12 months) after TBI. Also a short synacthen test and GHRH + Arginine tests will be performed in the sub-acutely (within one month) and long-term (6 month and 12 months).

—

Secondary

Measure	Time frame
1. Clinical and radiological markers are measured using the clinical information available at the time of presentation to hospital and serial MRI of the pituitary gland performed acutely, within one month and long-term (6 to 12 months) in a subset of patients to try to predict the occurrence of PTPD 2. Optimal timing for surveillance for PTPD using the clinical and radiological information detailed above 3. Functional recovery of patients with PTPD using Glasgow Outcome Score (eGOS) at end of study period (six to 12 months)	—

Measure

Time frame

1. Clinical and radiological markers are measured using the clinical information available at the time of presentation to hospital and serial MRI of the pituitary gland performed acutely, within one month and long-term (6 to 12 months) in a subset of patients to try to predict the occurrence of PTPD 2. Optimal timing for surveillance for PTPD using the clinical and radiological information detailed above 3. Functional recovery of patients with PTPD using Glasgow Outcome Score (eGOS) at end of study period (six to 12 months)

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Countries

United Kingdom

Contacts

Public ContactJohn Emelifeonwu

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026