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Trials / Completed

CompletedNCT00507104

Pituitary Functions After Traumatic Brain Injury (TBI) and/or Subarachnoid Hemorrhage (SAH)

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

Status
Completed
Phase
Study type
Observational
Enrollment
100 (actual)
Sponsor
University of Erlangen-Nürnberg Medical School · Academic / Other
Sex
All
Age
15 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Timeline

Start date
2006-09-01
Primary completion
2008-11-01
Completion
2008-11-01
First posted
2007-07-25
Last updated
2020-12-14

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT00507104. Inclusion in this directory is not an endorsement.