Table 1.
All patients (n = 356) |
Erythropoietin (n = 175) |
Placebo (n = 181) |
|
---|---|---|---|
Age (years)—Median [IQR] | 27.7 [21.4–47.4] | 28.2 [20.7–46.8] | 27.5 [21.5–47.7] |
Female sex—n (%) | 66 (18) | 30 (17) | 36 (20) |
Cause of injury—n (%) | |||
Motor vehicle accident | 158 (44) | 73 (42) | 85 (47) |
Motorcycle | 41 (12) | 23 (13) | 18 (10) |
Bicycle | 9 (2) | 4 (2) | 5 (3) |
Pedestrian | 38 (11) | 19 (11) | 19 (11) |
Fall/jump | 75 (21) | 42 (24) | 33 (18) |
Hit by object | 25 (7) | 11 (6) | 14 (8) |
Other | 10 (3) | 3 (2) | 7 (4) |
Severe Traumatic Brain Injury—n (%) | 267 (75) | 131 (75) | 136 (75) |
Moderate Traumatic Brain Injury—n (%) | 89 (25) | 44 (25) | 45 (25) |
Pupillary response—n (%) | |||
Both reacting | 293 (82) | 142 (81) | 151 (83) |
Dilated and both non-reactive | 1 (0.3) | 0 (0) | 1 (1) |
Both non-reactive | 27 (8) | 11 (6) | 16 (9) |
One non-reactive | 31 (9) | 20 (11) | 11 (6) |
Unknown | 4 (1) | 2 (1) | 2 (1) |
Hypotension—n (%) | 124 (35) | 65 (37) | 59 (33) |
Hypoxia—n (%) | 77 (22) | 40 (23) | 37 (20) |
Haemoglobin at baseline (g/L)—Mean (STD) | 118 (21.1) | 119 (20.4) | 117 (21.7) |
APACHE II Score—Mean (STD) | 20.6 (7.1) | 21 (7.4) | 20.1 (6.7) |
Injury Severity Score—Mean (STD) | 27 (10) | 27.3 (9.3) | 26.7 (10.6) |
IMPACT-TBI probability of poor outcome—Mean (STD) | 0.46 (0.23) | 0.47 (0.24) | 0.46 (0.23) |
Abbreviated Injury Head Score—Median [IQR] | 4 [3–5] | 4 [3–5] | 4 [3–5] |
Marshall CT classification—n (%) | |||
I | 13 (4) | 8 (5) | 5 (3) |
II | 216 (61) | 108 (62) | 108 (60) |
III | 47 (13) | 21 (12) | 26 (14) |
IV | 12 (3) | 6 (3) | 6 (3) |
V | 8 (3) | 3 (2) | 5 (3) |
VI | 60 (17) | 29 (17) | 31 (17) |
Time from injury to randomization, hr—Mean (STD) | 17.9 (5.6) | 18 (5.34) | 17.8 (5.85) |
Time from injury to first dose, hr—Mean (STD) | 19.2 (5.3) | 19.2 (5.1) | 19.1 (5.6) |
APACHE acute physiology and chronic health evaluation, CT computed tomography, IMPACT-TBI International Mission for Prognosis and Analysis of Clinical Trials in traumatic brain injury