Table 1.
Inclusion and exclusion criteria.
| Inclusion criteria | Exclusion criteria |
|---|---|
| 1. Non-penetrating TBI | 1. History of pre-existing neurologic disease (such as brain tumors, meningitis, cerebral palsy, encephalitis, brain abscesses, vascular malformations, cerebrovascular disease, Alzheimer's disease, multiple sclerosis, or HIV-encephalitis) |
| 2. Age 16–65 years | 2. History of premorbid disabling condition that interfere with outcome assessments |
| 3. Randomization within 2–24 weeks of injury. | 3. Contraindication to rhGH therapy (hypersensitivity to rhGH or any of the components of the supplied product, including metacresol, glycerin, or benzyl alcohol) |
| 4. Rancho Los Amigos Rating IV or better at the time of randomization. Should not be at Rancho IV level for more than 18 weeks before randomization | 4. Penetrating traumatic brain injury |
| 5. Availability of caregiver to oversee administration of medications | 5. Discharged from rehabilitation on insulin therapy and/or hypoglycemic agents |
| 6. Reasonable expectation for completion of outcome measures | 6. Obesity (BMI > 35) |
| 7. Residence inside the United States | 7. Active infection |
| 8. Hypothyroidism or Adrenal Insufficiency | |
| 9. Previous diagnosis of renal or hepatic failure | |
| 10. Active malignant disease | |
| 11. Acute critical illness, heart failure, or acute respiratory failure | |
| 12. Membership in a vulnerable population (prisoner) | |
| 13. Pregnancy. Women of childbearing age will be given a pregnancy test during screening to exclude pregnancy | |
| 14. Lactating females |