Recombinant Human Growth Hormone During Rehabilitation From Traumatic Brain Injury.

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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 rehabilitation1. However, there is no accepted gold standard for diagnosing GH deficiency in this population. Further, the major effector molecule of the somatotropic axis, Insulin-Like Growth Factor-1 (IGF-1) has recently been recognized as an important neurotrophic agent. Since most repair and regeneration after TBI occurs within the first few months after injury, absolute or relative deficiencies of GH and IGF-1 in the subacute period after TBI are potentially important factors why some patients fail to make a good functional recovery. The proposed study is a randomized, double-blind, placebo-controlled trial of rhGH, starting at 1 month post TBI, continuing for 6 months.

This study has one primary hypothesis, that treatment with recombinant human Growth Hormone (rhGH) in the subacute period after TBI results in improved functional outcome 6 months after injury. As secondary hypotheses, we will investigate what is the optimal method to diagnose GH deficiency in TBI survivors and study the relationship between GH deficiency and insufficiency and functional recovery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania; University of Texas Southwestern Medical Center
• Collaborator: Baylor Health Care System
• Treatments: Hormones

Criteria

Inclusion Criteria:

1. Non-penetrating TBI

2. Age 18 - 50 years.

3. 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.

4. Randomization within 2 - 10 weeks of injury.

5. 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.

6. GH deficiency diagnosed by either of the following two criteria:

1. . Peak GH response to L-arginine stimulation test < 1.4 microg/L; or

2. . Plasma IGF-1 level 1 SD below the expected median for age and body weight.

7. Availability of caregiver to oversee administration of medications.

8. Reasonable expectation for completion of outcome measures

9. Residence inside the United States

Exclusion Criteria:

1. 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)

2. History of premorbid disabling condition that interfere with outcome assessments

3. Contraindication to rhGH therapy. (hypersensitivity to rhGH or any of the components of the supplied product, including metacresol, glycerin, or benzyl alcohol)

4. Penetrating traumatic brain injury

5. Diabetes mellitus.

6. Obesity (BMI > 30).

7. Active infection.

8. Active malignant disease.

9. Acute critical illness, heart failure, or acute respiratory failure

10. Previous hospitalization for TBI > 1 day

11. Membership in a vulnerable population (prisoner)

12. Pregnancy. Women of childbearing age will be given a pregnancy test during screening to exclude pregnancy.

13. Lactating females