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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON30285

Enrollment

600

Registered

2007-01-23

Start date

2007-01-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

traumatologische aandoeningen brain injury caused by trauma traumatic brain injury

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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 = 18 years and

Exclusion criteria

Exclusion criteria: 1. Age > 65 years or 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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results