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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by University of Erlangen-Nürnberg Medical School.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT00507104
First received: July 24, 2007
Last updated: September 27, 2007
Last verified: July 2007
  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

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: Prospective Longitudinal Study on Pituitary Functions After TBI and/or SAH

Resource links provided by NLM:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

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

Additional relevant MeSH terms:
Pituitary Diseases
Hemorrhage
Hypopituitarism
Subarachnoid Hemorrhage
Brain Injuries
Wounds and Injuries
Pathologic Processes
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 18, 2014