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 sitesNovember 2, 2006

Overview

No summary available.

Registry

who.int

Start Date

November 2, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity Medical Center St Radboud, department of neurology

•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)