isolated growth hormone deficiency after traumatic brain injury
Conditions
Interventions
Trade Name: recombinant growth hormone
Pharmaceutical Form: Solution for injection
Sponsors
University Medical Center St Radboud, department of neurology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Age > 65 or 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ;Main Objective: 1. To determine whether, in patients with a history of mild, moderate or severe TBI, a GHD is associated with an impairment in cardiovascular performance, a proatherogenic profile, a change in body composition (less free fat mass), a reduction in quality of life and an impairment in functional recovery. 2. To determine whether an intervention with recombinant GH has beneficial effects on the variables as mentioned under 1.;Primary end point(s): 1.Change in different components of the GHD syndrome (anthropometric characteristics, cardiovascular performance and risk profile, cognitive function and QoL), before and after GH substitution, in patients with TBI 2.Change in physical and neuro-cognitive factors such as Glasgow Outcome Score-extended version, not necessarily associated with GHD syndrome, before and after GH substitution, in patients with TBI | — |
Countries
Netherlands
Outcome results
None listed