Table 1.
Factor 1 (Epo Study Drug) |
Factor 2a (Transfusion Threshold) |
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Epo 1 Regimen (n=38) |
Epo 2 Regimen (n=64) |
Placebo (n=98) |
Transfusion Threshold 7 g/dl (n=99) |
Transfusion Threshold 10 g/dl (n=101) |
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DEMOGRAPHIC CHARACTERISTICS | |||||
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Age, median (25th-75th) | 31·5 (23-48) |
29 (23-47) |
30 (22-44) |
28 (21-48) |
31 (24-45) |
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Gender, n (%) | |||||
Female | 4 (10·5) | 8 (12·5) | 14 (14·3) | 14 (14.1) | 12 (11.9) |
Male | 34 (89·5) | 55 (85·9) | 84 (85·7) | 85 (85.9) | 88 (87.1) |
Male living as female | 1 (1·6) | 1 (1.0) | |||
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Race/Ethnicity, n (%) | |||||
Asian | 1 (2·6) | 1 (1·6) | 4 (4·1) | 3 (3.0) | 3 (3.0) |
Hispanic | 20 (52·6) | 35 (54·7) | 48 (49·0) | 50 (50.5) | 53 (52.5) |
Black | 7 (18·4) | 10 (15·6) | 26 (26·5) | 20 (20.2) | 23 (22.8) |
White, non-Hispanic | 10 (26·3) | 18 (28·1) | 20 (20·4) | 26 (26.3) | 22 (21.8) |
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BASELINE INJURY CHARACTERISTICS | |||||
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Mechanism of Injury, n (%) | |||||
Assault | 2 (5·3) | 5 (7·8) | 15 (15·3) | 7 (7.1) | 15 (14.9) |
Fall/jump | 11 (28·9) | 7 (10·9) | 9 (9·2) | 18 (18.2) | 9 (8.9) |
Automobile accident | 19 (50) | 41 (64·1) | 56 (57·1) | 58 (58.6) | 58 (57.4) |
Motorcycle accident | 5 (13·2) | 11 (17·2) | 15 (15·3) | 14 (14.1) | 17 (16.8) |
Other | 1 (2·6) | 0 | 3 (3·1) | 2 (2.0) | 2 (2.0) |
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Enrollment motor GCSb, n (%) | |||||
4-5 | 26 (68·4) | 38 (59·4) | 65 (66·3) | 63 (63.6) | 66 (65.4) |
1-3 | 12 (31·6) | 26 (40·6) | 33 (33·7) | 36 (36.4) | 35 (34.7) |
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ED pupil reactivity, n (%) | |||||
Both reactive | 25 (65·8) | 41 (64·1) | 55 (56·1) | 63 (63.6) | 58 (57.4) |
One reactive | 5 (13·2) | 5 (7·8) | 13 (13·3) | 14 (14.1) | 9 (8.9) |
Neither reactive | 8 (21·1) | 18 (28·1) | 30 (30·6) | 22 (22.2) | 34 (33.7) |
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Enrollment sum GCSc, n (%) | |||||
GCS > 8 | 18 (47.4) | 29 (45.3) | 42 (42.9) | 42 (42.4) | 47 (46.5) |
GCS 6-8 | 8 (21.1) | 12 (18.8) | 25 (25.5) | 23 (23.2) | 22 (21.8) |
GCS 3-5 | 12 (31.6) | 23 (35.9) | 31 (31.6) | 34 (34.3) | 32 (31.7) |
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ED Marshall CT scan category, n (%) |
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Diffuse injury 1 or 2 | 15 (39·5) | 30 (46·9) | 44 (44·9) | 49 (49.5) | 40 (39.6) |
Diffuse injury 3 or 4 | 14 (36·8) | 10 (15·6) | 22 (22·5) | 23 (23.2) | 23 (22.8) |
Mass lesion | 9 (23·7) | 24 (37·5) | 32 (32·7) | 27 (27.3) | 38 (37.6) |
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ED CT scan, subarachnoid hemorrhage present, n (%) |
26 (68·4) | 44 (68·8) | 68 (69·4) | 71 (71.7) | 67 (66.3) |
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ED CT scan, epidural hematoma present, n (%) |
6 (15·8) | 12 (18·8) | 14 (14·3) | 10 (10.1) | 22 (21.8) |
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Surgery on admission, n (%) | 9 (23.7) | 22 (34.4) | 30 (30.6) | 26 (26.3) | 35 (34.7) |
Epidural hematoma | 0 | 3 (4.7) | 6 (6.1) | 3 (3.0) | 6 (5.9) |
Subdural hematoma | 7 (18·4) | 19 (29·7) | 20 (20.4) | 20 (20.2) | 26 (25.7) |
Intracerebral hematoma/contusion |
2 (5·3) | 0 | 2 (2.0) | 2 (2.0) | 2 (2.0) |
Non-CNS injury | 0 | 0 | 2 (2.0) | 1 (1.0) | 1 (1.0) |
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Prehospital hypotension, n (%) | 4 (10.5) | 5 (7.8) | 16 (16.3) | 11 (11.1) | 14 (13.9) |
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Prehospital hypoxia, n (%) | 3 (7.9)** | 7 (10.9) | 29 (29.6) | 18 (18.2) | 21 (20.8) |
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Injury Severity Score, median (25th-75th) |
27 (26-35) |
29 (25-36.5) |
29 (25-38) |
29 (25-38) |
29 (25-35) |
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IMPACT probability of poor outcome, mean (sd) |
0.39 (0.3) | 0.40 (0.2) | 0.41 (0.3) | 0.43 (0.3) | 0.39 (0.3) |
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ED Hemoglobin (g/dl), median (25th-75th) |
14.7 (13.5-15.6) |
14.6 (12.8-15.5) |
14.2 (12.7-15.6) |
14.4 (13-15.6) |
14.6 (12.8-15.5) |
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ED Glucose (mmol/L), median (25th-75th) |
8.5 (7.2-10.7) |
8.8 (7.1-10.1) |
8.2 (6.9-10.1) |
8.7 (7.3-10.4) |
8.0 (6.-10.0) |
Factors 1 and 2 include the same patients
motor GCS = motor component of the Glasgow Coma Score, which ranges from 1 (no motor response) to 6 (follows commands)
sum GCS = sum of the eye, motor, and verbal components of the Glasgow Coma Score, which ranges from 3 (no responses) to 15 (normal responses)