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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00507104
Other study ID # pitfunction_TBI_SAH
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2006
Est. completion date November 2008

Study information

Verified date December 2020
Source University of Erlangen-Nürnberg Medical School
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date November 2008
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender All
Age group 15 Years and older
Eligibility Inclusion Criteria: - TBI or SAH - Control group: injury without involvement of the brain/skull Exclusion Criteria: - Pregnancy

Study Design


Locations

Country Name City State
Germany Department of Neurosurgery, University of Erlangen Erlangen

Sponsors (2)

Lead Sponsor Collaborator
University of Erlangen-Nürnberg Medical School Pfizer

Country where clinical trial is conducted

Germany, 

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