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

NCT00507104

Last updated date
Study Location
Department of Neurosurgery, University of Erlangen
Erlangen, , 91054, Germany
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Traumatic Brain Injury, Subarachnoid Hemorrhage, Hypopituitarism
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
15 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- TBI or SAH

- Control group: injury without involvement of the brain/skull

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Pregnancy

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Traumatic Brain Injury, Subarachnoid Hemorrhage, HypopituitarismPituitary Functions After Traumatic Brain Injury (TBI) and/or Subarachnoid Hemorrhage (SAH)
NCT00507104
  1. Erlangen,
ALL GENDERS
15 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Pituitary Functions After Traumatic Brain Injury (TBI) and/or Subarachnoid Hemorrhage (SAH)
Official Title Prospective Longitudinal Study on Pituitary Functions After TBI and/or SAH
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.
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 Observational
Study Design Observational Model: Defined Population
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Traumatic Brain Injury
  • Subarachnoid Hemorrhage
  • Hypopituitarism
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September 27, 2007)
100
Original Enrollment Not Provided
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
Sex/Gender
Sexes Eligible for Study:All
Ages 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT00507104
Other Study ID Numbers pitfunction_TBI_SAH
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor University of Erlangen-Nürnberg
Collaborators 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
PRS Account University of Erlangen-Nürnberg Medical School
Verification Date July 2007