PITUITARY DAMAGE AFTER TRAUMATIC BRAIN INJURY; Occurrence of growth hormone deficiency at long term follow-up and the beneficial effects of growth hormone substitution on cardiovascular performance, quality of life and functional abilities - Growth hormone substitution in isolated growth hormone deficiency after traumatic brain injury

niversity Medical Center St Radboud, department of neurology0 个研究点开始时间: 2006年11月2日最近更新: 2012年3月19日

适应症

试验速览

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•1. The patient visits the emergency department with mild, moderate or 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. The trauma has occurred less than 24 hours before visiting the emergency department.
•3. Age = 18 years and = 65 years at the time of inclusion
•4. Absolute growth hormone deficiency (defined as growth hormone response < 9 mE/l in the GHRH-arginine test), diagnosed within one of the protocols going with ABR form no. 14996 or 14998
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Age > 65 or < 18 years
•2. No oral or written informed consent by patient or proxy
•3. Pre-existent neuro-endocrine disorder
•4. Co-existent dysfunction of pituitary axis other than the somatotropic axis
•5. Instable infiltrative disease in the hypothalamus/pituitary region (eg sarcoidosis, tumour metastasis)
•6. BMI >30 kg/m2
•7. Primary dyslipidemia that necessitates treatment
•8. Positive family history of premature cardiovascular disease
•9. Overt diabetes mellitus type II (including a history of gestational diabetes mellitus)
•10. Impairment in renal function (Creatinin clearance < 60 ml/min)
•11. Pregnancy or wish for pregnancy during the study period, lactation
•12. Retinal disease
•13. Co-existent disease with decreased life expectancy, especially active malignant tumor
•14. Chronic alcohol or drug abuse

发起方

niversity Medical Center St Radboud, department of neurology