Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00507104
Status:
COMPLETED
Last Update Posted:
2020-12-14
First Post:
2007-07-24
Brief Title:
Pituitary Functions After Traumatic Brain Injury TBI andor Subarachnoid Hemorrhage SAH
Sponsor:
University of Erlangen-Nürnberg Medical School
Organization:
University of Erlangen-Nürnberg Medical School
Study Overview
Official Title:
Prospective Longitudinal Study on Pituitary Functions After TBI andor SAH
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study performs assessments of pituitary functions by basal hormone levels in the acute phase after TBI andor 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
Detailed Description:
Recent data have demonstrated that hypopituitarism seems to be a frequent finding after traumatic brain injury TBI andor 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None