Pituitary Functions After Traumatic Brain Injury (TBI) and/or Subarachnoid Hemorrhage (SAH)
Recruitment status was Recruiting
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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 Time Perspective: Prospective |
| Official Title: | Prospective Longitudinal Study on Pituitary Functions After TBI and/or SAH |
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2006 |
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 |
Inclusion Criteria:
- TBI or SAH
- Control group: injury without involvement of the brain/skull
Exclusion Criteria:
- Pregnancy
Contacts and Locations| 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 |
| Germany | |
| Department of Neurosurgery, University of Erlangen | Recruiting |
| Erlangen, Germany, 91054 | |
| 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:
|
Hemorrhage Hypopituitarism Subarachnoid Hemorrhage Brain Injuries Pathologic Processes Pituitary Diseases 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 Wounds and Injuries |
ClinicalTrials.gov processed this record on June 17, 2013