跳至主要内容
临床试验/NCT00507104
NCT00507104已完成不适用

Prospective Longitudinal Study on Pituitary Functions After TBI and/or SAH

University of Erlangen-Nürnberg Medical School1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2006年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1

研究概览

简要总结

This study performs assessments of pituitary functions by basal hormone levels in the acute phase after TBI and/or SAH followed by detailed endocrine tests (insulin-induced hypoglycemia or growth hormone releasing hormone-arginine-corticotropin releasing hormone-leuteinizing hormone releasing hormone [GHRH-arginine-CRH-LHRH] test) after 4 and 12 months.

详细描述

Recent data have demonstrated that hypopituitarism seems to be a frequent finding after traumatic brain injury (TBI) and/or subarachnoid hemorrhage (SAH). However, most of these studies referred to retrospective evaluations. There are only few prospective data, and no longitudinal study routinely taking into account the assessment of anterior pituitary function in the acute phase after TBI or SAH so far.

We prospectively evaluate pituitary functions in patients in the acute phase after TBI or SAH and a control group of patients with trauma not involving the brain. Endocrine data included basal anterior pituitary lobe hormone, IGF-1 and testosterone serum levels (Immulite 2000) within the first 8 hours after TBI or SAH. Further endocrine evaluation was performed by means of either a combined GHRH-arginine-CRH-LHRH test or an insulin-induced hypoglycemia test after 4 months and 12 months. To rule out an assay related bias with regard to GH and IGF-1, all hormone levels were cross-checked by a supersensitive assay in another laboratory.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • TBI or SAH
  • Control group: injury without involvement of the brain/skull

排除标准

  • Pregnancy

研究者

发起方
University of Erlangen-Nürnberg Medical School
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验