Pituitary Functions After Traumatic Brain Injury (TBI) and/or Subarachnoid Hemorrhage (SAH)
Recruitment status was Recruiting
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.
Traumatic Brain Injury
|Study Design:||Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
|Official Title:||Prospective Longitudinal Study on Pituitary Functions After TBI and/or SAH|
|Study Start Date:||September 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00507104
|Contact: Juergen Kreutzer, M.D.||++email@example.com|
|Contact: Michael Buchfelder, M.D., Ph.D.||++firstname.lastname@example.org|
|Department of Neurosurgery, University of Erlangen||Recruiting|
|Erlangen, Germany, 91054|
|Study Chair:||Michael Buchfelder, M.D., Ph.D.||Department of Neurosurgery, University of Erlangen|
|Principal Investigator:||Juergen Kreutzer, M.D.||Department of Neurosurgery, University of Erlangen|
|Principal Investigator:||Christioph Schöfl, M.D., Ph.D.||Department of Neurosurgery, Division Neuroendocrinology, University of Erlangen|
|Principal Investigator:||Andrea Kleindienst, M.D.||Department of Neurosurgery, University of Erlangen|