Anterior Pituitary Hormone Replacement in Traumatic Brain Injury

Completed · Phase 4

Conditions studied: Growth Hormone Deficiency, Traumatic Brain Injury

In brief

Fifteen to twenty percent of adults who suffer a traumatic brain injury (TBI) that requires hospitalization and rehabilitation have been found to have growth hormone (GH) deficiency by GH stimulation testing. Moreover, abnormalities have also been established for the cortisol and thyroid axis. The hypothesis of this proposal is that hormone replacement in TBI patients with documented abnormalities in the GH, thyroid, or cortisol axis will improve muscle function, body composition, aerobic capacity (GH) and tests of neuropsychologic function (GH, thyroid, cortisol).

Key facts

Study ID

NCT00957671

Run by

The University of Texas Medical Branch, Galveston

People needed

15

Starts

2003-11-01

Expected to finish

2015-10-01

Last updated by the study team

2018-06-29

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged 21 and older.
• Documented moderate to severe traumatic brain injury at least one year post injury.

You may not qualify if…

• The only absolute exclusionary medication will be an anticoagulant (Coumadin) because of the risk of bleeding during the possible muscle biopsy procedure and daily injections of rhGH in the GH arm of the study.
• Any subject with a history of hepatitis or a 3-fold elevation of liver function tests (Alk phos, alanine aminotransferase (ALT), aspartate aminotransferase (AST)). We are uncertain of the effects of hormone replacement such as rhGH on the liver, so we will exclude any subjects with hepatitis. This exclusion applies only to subjects who would be enrolled in the GH arm of the study.
• Subjects who are deficient in cortisol or thyroid at screening will be excluded until hormone abnormalities have been corrected.
• Subjects with chronic pain who are being managed with narcotics will be excluded as the effects of central nervous system depressants may interfere with study test results.

Where it is running

• Transitional Learning Center — Galveston, Texas, United States
• The University of Texas Medical Branch at Galveston — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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