Pituitary Functions After Traumatic Brain Injury (TBI) and/or Subarachnoid Hemorrhage (SAH)
|ClinicalTrials.gov Identifier: NCT00507104|
Recruitment Status : Unknown
Verified July 2007 by University of Erlangen-Nürnberg Medical School.
Recruitment status was: Recruiting
First Posted : July 25, 2007
Last Update Posted : September 28, 2007
|Condition or disease|
|Traumatic Brain Injury Subarachnoid Hemorrhage Hypopituitarism|
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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Observational Model:||Defined Population|
|Official Title:||Prospective Longitudinal Study on Pituitary Functions After TBI and/or SAH|
|Study Start Date :||September 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00507104
|Contact: Juergen Kreutzer, M.D.||++firstname.lastname@example.org|
|Contact: Michael Buchfelder, M.D., Ph.D.||++email@example.com|
|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|