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

Sponsor

University of Erlangen-Nürnberg Medical School (Other)

Overall Status

Completed

CT.gov ID

NCT00507104

Collaborator

Pfizer (Industry)

100

Enrollment

Location

Actual Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury Subarachnoid Hemorrhage Hypopituitarism

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.

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Nov 1, 2008

Actual Study Completion Date :

Nov 1, 2008

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

TBI or SAH
Control group: injury without involvement of the brain/skull

Exclusion Criteria:

Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Neurosurgery, University of Erlangen	Erlangen		Germany	91054

Sponsors and Collaborators

University of Erlangen-Nürnberg Medical School
Pfizer

Investigators

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