Table 3.
Baseline characteristics by treatment group and overall.
|
All with 6 month f/u (n = 40) |
rhGH (n = 20) |
Placebo (n = 20) |
p-value | |
|---|---|---|---|---|
| Age (years), mean (STD) | 31.1 (14.3) | 32.2 (15.2) | 30.1 (13.7) | 0.656 |
| Gender, Male, n (%) | 34 (85) | 17 (85) | 17 (85) | 1.00 |
| Ethnicity, Hispanic, n (%) | 6 (15) | 3 (15) | 3 (15) | 1.00 |
| Race, White, n (%) | 37 (92.5) | 18 (90) | 19 (95) | 0.548 |
| Injury Mechanism | 0.037 | |||
| Motor vehicle, n (%) | 18 (45) | 5 (25) | 13 (65) | |
| Other vehicular, n (%) | 15 (37.5) | 9 (45) | 6 (30) | |
| Fall, n (%) | 3 (7.5) | 3 (15) | 0 (0) | |
| Other, n (%) | 4 (10) | 3 (15) | 1 (5) | |
| Days from injury to randomization, mean (STD) | 64.1 (35.9) | 65.7 (30.4) | 62.5 (41.4) | 0.782 |
| Severity as measured by Glascow Coma Score (GCS) and Post-traumatic Amnesia (PTA)* | 0.186 | |||
| Mild, n (%) | 4 (10) | 3 (15) | 1 (5) | |
| Moderate, n (%) | 3 (7.5) | 0 (0) | 3 (15) | |
| Severe, n (%) | 32 (80) | 17 (85) | 15 (75) | |
| Unknown/Missing, n (%) | 1 (2.5) | 0 (0) | 1 (5) | |
| Disability Rating Scale (DRS), mean (STD) | 8 (4.1) | 7.6 (3) | 8.4 (5.1) | 0.546 |
| FUNCTIONAL INDEPENDENCE MEASURE (FIM) ADMIT | ||||
| Motor, mean (STD) | 38.3 (18.4) | 31.7 (17.4) | 44.3 (17.6) | 0.033 |
| Cognitive, mean (STD) | 9.3 (6.0) | 7.3 (4.8) | 11.1 (6.6) | 0.053 |
| Total, mean (STD) | 47.7 (22.2) | 39.1 (20.3) | 55.4 (21.5) | 0.022 |
| FIM DISCHARGE | ||||
| Motor, mean (STD) | 79.0 (22.0) | 80.0 (23.0) | 78.0 (21.5) | 0.784 |
| Cognitive, mean (STD) | 23.9 (8.1) | 23.2 (7.1) | 24.6 (9.1) | 0.590 |
| Total, mean (STD) | 102.9 (28.4) | 103.2 (28.0) | 102.6 (29.5) | 0.952 |
| FIM CHANGE | ||||
| Motor, mean (STD) | 39.0 (17.1) | 44.5 (17.9) | 33.7 (14.9) | 0.043 |
| Cognitive, mean (STD) | 14.5 (7.3) | 15.5 (6.7) | 13.5 (7.9) | 0.408 |
| Total, mean (STD) | 53.5 (22.2) | 60.4 (21.0) | 47.2 (21.8) | 0.066 |
| IGF-1 below age and gender specific mean, n (%) | 21 (54) | 12 (60) | 9 (47.7) | 0.525 |
| IGF-1<1 STD below mean, n (%) | 6 (15.4) | 3 (15.8) | 3 (15) | 0.946 |
| Peak L-Arginine (n = 24), median [IQR] | 1.3 [0.5, 5.8] | 2.2 [0.6, 5.9] | 1.2 [0.5, 5.7] | 0.395 |
| CVLT Score, mean (STD) | 29.4 (17.0) | 25.4 (18.7) | 33.4 (14.9) | 0.093 |
| CVLT t-score, mean (STD) | 30.5 (17.8) | 27.2 (18.6) | 34 (16.9) | 0.159 |
| Trails A Score, mean (STD) | 54.7 (23.7) | 57.8 (25.9) | 51.9 (22.1) | 0.462 |
| Trails A t-score, mean (STD) | 26.5 (14.6) | 26 (16.3) | 27.1 (13.4) | 0.908 |
| Trails B Score, mean (STD) | 156.4 (97.9) | 142 (106.8) | 167.8 (92.7) | 0.603 |
| Trails B t-score, mean (STD) | 29.7 (18.3) | 28.7 (19.4) | 30.5 (18.1) | 0.908 |
*
Severity defined according to Mayo classification system: Malec et al. (18). Bold values highlight those that meet the pre-specified nominal threshold for statistical significance (p < 0.05).