NL-OMON30305尚未招募4 期
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 TBI
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
排除标准
- •1. Age > 65 or < 18 years
- •2. No oral or written informed consent by patient
- •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. History of neoplasmata
- •14. Co-existent disease with decreased life expectancy, especially active malignant tumor
- •15. Chronic alcohol or drug abuse
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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 injuryisolated growth hormone deficiency after traumatic brain injuryEUCTR2006-005442-37-NLniversity Medical Center St Radboud, department of neurology
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