- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00507104
Pituitary Functions After Traumatic Brain Injury (TBI) and/or Subarachnoid Hemorrhage (SAH)
Prospective Longitudinal Study on Pituitary Functions After TBI and/or SAH
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Erlangen, Germany, 91054
- Department of Neurosurgery, University of Erlangen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- TBI or SAH
- Control group: injury without involvement of the brain/skull
Exclusion Criteria:
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Collaborators and Investigators
Collaborators
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Endocrine System Diseases
- Craniocerebral Trauma
- Trauma, Nervous System
- Hypothalamic Diseases
- Pituitary Diseases
- Intracranial Hemorrhages
- Brain Injuries
- Hemorrhage
- Brain Injuries, Traumatic
- Subarachnoid Hemorrhage
- Hypopituitarism
Other Study ID Numbers
- pitfunction_TBI_SAH
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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