Status:
COMPLETED
Anterior Pituitary Hormone Replacement in Traumatic Brain Injury
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Collaborating Sponsors:
The Moody Foundation
Conditions:
Growth Hormone Deficiency
Traumatic Brain Injury
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief Summary
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 ...
Detailed Description
This protocol is designed to screen and detect evidence of pituitary hormone deficiency in adults following traumatic brain injury. Growth hormone deficiency will be replaced for a period of one year....
Eligibility Criteria
Inclusion
- Patients aged 21 and older.
- Documented moderate to severe traumatic brain injury at least one year post injury.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00957671
Start Date
November 1 2003
End Date
October 1 2015
Last Update
June 29 2018
Active Locations (2)
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1
Transitional Learning Center
Galveston, Texas, United States, 77550
2
The University of Texas Medical Branch at Galveston
Galveston, Texas, United States, 77555