Anterior Pituitary Hormone Replacement in Traumatic Brain Injury

Condition(s) targeted: Growth Hormone Deficiency; Traumatic Brain Injury

Intervention: Human Growth Hormone (Drug); Placebo (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: The University of Texas Medical Branch, Galveston

Official(s) and/or principal investigator(s):
Randall J Urban, M.D., Principal Investigator, Affiliation: The University of Texas Medical Branch at Galveston

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).

Official title: Anterior Pituitary Hormone Replacement in Traumatic Brain Injury

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Determine the effect of recombinant human growth hormone (rhGH) replacement on neuropsychologic function in individuals with growth hormone deficiency following traumatic brain injury

Secondary outcome:

Determine the effect of recombinant human growth hormone (rhGH) replacement on muscle function function in individuals with growth hormone deficiency following traumatic brain injury

Determine the effect of recombinant human growth hormone (rhGH) replacement on body composition in individuals with growth hormone deficiency following traumatic brain injury

Determine the effect of recombinant human growth hormone (rhGH) replacement on aerobic capacity in individuals with growth hormone deficiency following traumatic brain injury

Detailed description: This protocol is designed to screen and detect evidence of pituitary hormone deficiency in adults following traumatic brain injury. Treatment period for thyroid or cortisol deficiency will be six months. Growth hormone deficiency will be replaced for a period of one year followed by a second year of open label treatment to allow individuals in the placebo group an opportunity to demonstrate a response to hormone replacement. Subject will not be screened until at least one year following brain injury to allow for natural recovery of hormone function.

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients aged 21 and older.

- Documented moderate to severe traumatic brain injury at least one year post injury.

Exclusion Criteria:

- 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.

The University of Texas Medical Branch at Galveston, Galveston, Texas 77555, United States

Transitional Learning Center, Galveston, Texas 77550, United States

Starting date: November 2003
Last updated: January 15, 2015