Pituitary dysfunction after traumatic brain injury: a new challenge in neurotraumatology

Conditions: traumatologische aandoeningen
brain injury caused by trauma
traumatic brain injury
10021112
10042258

Registration Number: NL-OMON30285

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 600

Inclusion Criteria

1. All patients who visit the emergency department with a mild, a moderate or a severe traumatic brain injury. (Mild traumatic brain injury is defined as a history of impact to the head and a Glasgow Coma Scale score (GCS) 13-15 at entry in the emergency room, moderate traumatic brain injury is defined as a GCS 9-12 at entry in the emergency room, and severe traumatic brain injury is defined as a GCS <= 8 at entry in the emergency room)
2. Initial trauma occurred less than 24 hours before visiting the Emergency Department.
3. Age >= 18 years and <= 65 years

Exclusion Criteria

1. Age > 65 years or < 18 years
2. No oral or written informed consent by patient or proxy
3. Pre-existent neuro-endocrine disorder
4. Instable infiltrative disease in the hypothalamus/pituitary region (eg sarcoidosis, tumour metastasis)
5. BMI >30 kg/m2
6. Pregnancy or wish for pregnancy during the study period women, lactation
7. Co-existent disease with decreased life expectancy, especially active malignant tumor
8. Chronic alcohol or drug abuse

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Protocol 1: Proportion of TBI patients who display a pituitary dysfunction<br /><br><br /><br>Protocol 2:<br /><br>a) Difference in volume of pituitary gland and hypothalamus<br /><br>b) Difference in structural connectivity between hypothalamus and hypothetical<br /><br>projections<br /><br>c) Differences in functional connectivity in the resting state<br /><br><br /><br>Protocol 3: Difference in functioning in daily living as expressed by<br /><br>GOS-E-score</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Protocol 1:<br /><br>a) Proportion of patients with a history of trauma without head injury that<br /><br>have pituitary dysfunction<br /><br>b) Difference in functioning in daily living as expressed by GOS-E-score<br /><br>c) Difference in abnormalities going with classical pituitary dysfunction, as<br /><br>assessed by a questionnaire, physical examination and cardiovascular analysis<br /><br>d) Difference in scores on questionnaires on quality of life, physical,<br /><br>cognitive and psychological functioning and fatigue<br /><br><br /><br>Protocol 2: Difference in structural cerebral defects<br /><br><br /><br>Protocol 3:<br /><br>a) Difference in scores on questionnaires on quality of life, physical,<br /><br>cognitive and psychological functioning and fatigue<br /><br>b) Difference in scores on neuropsychological evaluation<br /><br>c) Difference in presence of biochemical pituitary dysfunction</p><br>