Status:
COMPLETED
Recombinant Human Growth Hormone During Rehabilitation From Traumatic Brain Injury.
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Baylor Health Care System
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
Growth Hormone (GH) deficiency, defined by insufficient GH response to a variety of stimulating compounds, is found in 20-35% of adults who suffer traumatic brain injuries (TBI) requiring inpatient re...
Detailed Description
1\. Patient selection and enrollment. Participants will be recruited into the study from subjects admitted for acute inpatient rehabilitation in the North Texas Traumatic Brain Injury Model Systems (N...
Eligibility Criteria
Inclusion
- Non-penetrating TBI
- Age 18 - 50 years.
- Admission to a North Texas Traumatic Brain Injury Model System-affiliated rehabilitation unit within 8 weeks of injury. Enrollment in TBI-MS database not required.
- Randomization within 2 - 10 weeks of injury.
- Rancho Los Amigos Rating IV or better at the time of randomization. Should not be at Rancho IV level for more than 4 weeks before randomization.
- GH deficiency diagnosed by either of the following two criteria:
- . Peak GH response to L-arginine stimulation test \< 1.4 microg/L; or
- . Plasma IGF-1 level 1 SD below the expected median for age and body weight.
- Availability of caregiver to oversee administration of medications.
- Reasonable expectation for completion of outcome measures
- Residence inside the United States
Exclusion
- History of pre-existing neurologic disease (such as epilepsy, brain tumors, meningitis, cerebral palsy, encephalitis, brain abscesses, vascular malformations, cerebrovascular disease, Alzheimer's disease, multiple sclerosis, or HIV-encephalitis)
- History of premorbid disabling condition that interfere with outcome assessments
- Contraindication to rhGH therapy. (hypersensitivity to rhGH or any of the components of the supplied product, including metacresol, glycerin, or benzyl alcohol)
- Penetrating traumatic brain injury
- Diabetes mellitus.
- Obesity (BMI \> 30).
- Active infection.
- Active malignant disease.
- Acute critical illness, heart failure, or acute respiratory failure
- Previous hospitalization for TBI \> 1 day
- Membership in a vulnerable population (prisoner)
- Pregnancy. Women of childbearing age will be given a pregnancy test during screening to exclude pregnancy.
- Lactating females
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00766038
Start Date
September 1 2008
End Date
December 1 2013
Last Update
November 18 2019
Active Locations (3)
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1
Center for NeuroSkills
Bakersfield, California, United States
2
Baylor University Medical Center
Dallas, Texas, United States, 75226
3
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-9036