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Pituitary Functions After Traumatic Brain Injury (TBI) and/or Subarachnoid Hemorrhage (SAH)
This study is currently recruiting participants.
Verified by University of Erlangen-Nürnberg, July 2007
Sponsors and Collaborators: University of Erlangen-Nürnberg
Pfizer
Information provided by: University of Erlangen-Nürnberg
ClinicalTrials.gov Identifier: NCT00507104
  Purpose

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
Traumatic Brain Injury
Subarachnoid Hemorrhage
Hypopituitarism

MedlinePlus related topics: Traumatic Brain Injury
U.S. FDA Resources
Study Type: Observational
Study Design: Screening, Longitudinal, Defined Population, Prospective Study
Official Title: Prospective Longitudinal Study on Pituitary Functions After TBI and/or SAH

Further study details as provided by University of Erlangen-Nürnberg:

Estimated Enrollment: 100
Study Start Date: September 2006
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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00507104

Contacts
Contact: Juergen Kreutzer, M.D. ++49-9131-8533001 kreutzer@nch.imed.uni-erlangen.de
Contact: Michael Buchfelder, M.D., Ph.D. ++49-9131-8534566 buchfelder@nch.imed.uni-erlangen.de

Locations
Germany
Department of Neurosurgery, University of Erlangen Recruiting
Erlangen, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg
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
  More Information

Study ID Numbers: pitfunction_TBI_SAH
Study First Received: July 24, 2007
Last Updated: September 27, 2007
ClinicalTrials.gov Identifier: NCT00507104  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Erlangen-Nürnberg:
traumatic brain injury
Subarachnoid Hemorrhage
Hypopituitarism

Study placed in the following topic categories:
Craniocerebral Trauma
Hypothalamic Diseases
Pituitary Diseases
Wounds and Injuries
Vascular Diseases
Disorders of Environmental Origin
Central Nervous System Diseases
Endocrine System Diseases
Trauma, Nervous System
Intracranial Hemorrhages
Hemorrhage
Brain Diseases
Cerebrovascular Disorders
Hypopituitarism
Subarachnoid Hemorrhage
Endocrinopathy
Brain Injuries

Additional relevant MeSH terms:
Pathologic Processes
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009