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

NCT ID: NCT00507104

Last Updated: 2020-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-11-30

Brief Summary

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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

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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.

Conditions

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Traumatic Brain Injury Subarachnoid Hemorrhage Hypopituitarism

Keywords

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traumatic brain injury Subarachnoid Hemorrhage Hypopituitarism

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnancy
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Buchfelder, M.D., Ph.D.

Role: STUDY_CHAIR

Department of Neurosurgery, University of Erlangen

Juergen Kreutzer, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Neurosurgery, University of Erlangen

Christioph Schöfl, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Neurosurgery, Division Neuroendocrinology, University of Erlangen

Andrea Kleindienst, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Neurosurgery, University of Erlangen

Locations

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Department of Neurosurgery, University of Erlangen

Erlangen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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pitfunction_TBI_SAH

Identifier Type: -

Identifier Source: org_study_id