Table 3.
Baseline characteristics and demographics
| Characteristic | As Randomized (N = 714)
|
As Treated (N =714)
|
Per Protocol (N = 590)
|
Major Protocol Violations (N = 124)
|
||||
|---|---|---|---|---|---|---|---|---|
| PolyHeme (N = 350) | Control (N = 364) | PolyHeme (N = 349) | Control (N = 365) | PolyHeme (N = 279) | Control (N = 311) | PolyHeme (N = 71) | Control (N = 53) | |
| Age (y)a | 36.3 (0.8) | 37.9 (0.9) | 35.9 (0.8) | 38.3 (0.9) | 36.7 (0.9) | 38.2 (0.9) | 35.0 (1.7) | 35.9 (2.3) |
|
| ||||||||
| Age category (APACHE)b | ||||||||
|
| ||||||||
| ≤44 y | 242 (69) | 251 (69) | 247 (71) | 246 (67) | 195 (70) | 211 (68) | 47 (66) | 40 (76) |
|
| ||||||||
| 45–54 y | 65 (19) | 57 (16) | 62 (18) | 60 (16) | 48 (17) | 51 (16) | 17 (24) | 6 (11) |
|
| ||||||||
| 55–64 y | 27 (8) | 27 (7) | 25 (7) | 29 (8) | 21 (8) | 24 (8) | 6 (9) | 3 (6) |
|
| ||||||||
| 65–74 y | 11 (3) | 16 (4) | 10 (3) | 17 (5) | 10 (4) | 14 (5) | 1 (1) | 2 (4) |
|
| ||||||||
| ≥75 y | 5 (1) | 13 (4) | 5 (1) | 13 (4) | 5 (2) | 11 (4) | 0 (0) | 2 (4) |
|
| ||||||||
| Maleb | 272 (78) | 289 (79) | 268 (77) | 293 (80) | 218 (78) | 252 (81) | 54 (76) | 37 (70) |
|
| ||||||||
| Ethnicityb | ||||||||
|
| ||||||||
| Caucasian | 160 (46) | 170 (47) | 156 (45) | 174 (48) | 127 (46) | 151 (49) | 33 (47) | 19 (36) |
|
| ||||||||
| African American | 124 (35) | 120 (33) | 124 (36) | 120 (33) | 97 (35) | 102 (33) | 27 (38) | 18 (34) |
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| ||||||||
| Hispanic | 53 (15) | 61 (17) | 57 (16) | 57 (16) | 43 (15) | 48 (15) | 10 (14) | 13 (25) |
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| ||||||||
| Asian | 10 (3) | 7 (2) | 9 (3) | 8 (2) | 9 (3) | 4 (1) | 1 (1) | 3 (6) |
|
| ||||||||
| Other | 3 (<1) | 6 (2) | 3 (<1) | 6 (2) | 3 (1) | 6 (2) | 0 | 0 |
|
| ||||||||
| Height (cm)a | 174.5 (0.6) | 173.4 (0.6) | 174.3 (0.6) | 173.6 (0.6) | 174.8 (0.7) | 173.9 (0.6) | 173.4 (1.7) | 170.1 (2.3) |
|
| ||||||||
| Weight (kg)a | 82.4 (1.1) | 83.2 (1.2) | 82.6 (1.1) | 83.0 (1.2) | 82.9 (1.3) | 84.0 (1.2) | 80.0 (2.5) | 78.1 (3.6) |
|
| ||||||||
| BMI (kg/m2)a | 27.0 (0.4) | 27.7 (0.4) | 27.1 (0.3) | 27.6 (0.4) | 27.1 (0.4) | 27.9 (0.4) | 26.5 (0.9) | 26.6 (1.2) |
|
| ||||||||
| ISSa | 19.9 (0.8) | 19.4 (0.7) | 20.1 (0.7) | 19.2 (0.7) | 19.1 (0.8) | 19.1 (0.8) | 22.9 (1.9) | 21.2 (1.9) |
|
| ||||||||
| ISS categoryb | ||||||||
|
| ||||||||
| Mild/moderate (<9) | 56 (16) | 60 (16) | 51 (15) | 65 (18) | 47 (17) | 53 (17) | 9 (13) | 7 (13) |
|
| ||||||||
| Serious (9–15) | 107 (31) | 101 (28) | 107 (31) | 101 (28) | 87 (31) | 90 (29) | 20 (28) | 11 (21) |
|
| ||||||||
| Severe (16–24) | 61 (17) | 74 (20) | 60 (17) | 75 (21) | 51 (18) | 67 (22) | 10 (14) | 7 (14) |
|
| ||||||||
| Critical/maximal (25–75) | 126 (36) | 123 (34) | 129 (37) | 120 (33) | 94 (34) | 99 (32) | 32 (45) | 24 (49) |
|
| ||||||||
| Maximal (36–75) | 48 (14) | 41 (11) | 46 (13) | 43 (12) | 36 (13) | 36 (12) | 12 (17) | 5 (9) |
|
| ||||||||
| Unsurvivable (75) | 3 (<1) | 1 (<1) | 3 (<1) | 1 (<1) | 1 (<1) | 1 (<1) | 2 (3) | 0 |
|
| ||||||||
| Mechanism of injuryb | ||||||||
|
| ||||||||
| Blunt | 166 (47) | 174 (48) | 165 (47) | 175 (48) | 138 (49) | 154 (50) | 28 (39) | 20 (40) |
|
| ||||||||
| Penetrating | 184 (53) | 186 (52) | 183 (53) | 187 (52) | 141 (51) | 156 (50) | 43 (61) | 30 (60) |
|
| ||||||||
| Transport modeb | ||||||||
|
| ||||||||
| Air | 121 (35) | 122 (34) | 117 (34) | 126 (35) | 99 (35) | 112 (36) | 22 (31) | 10 (19) |
|
| ||||||||
| Ground | 229 (65) | 242 (66) | 232 (66) | 239 (65) | 180 (65) | 199 (64) | 49 (69) | 43 (81) |
|
| ||||||||
| Median Transport Time (min)a | 26 | 26 | 26 | 26 | 27 | 26 | 24 | 26 |
|
| ||||||||
| SBP randomization (mm Hg)a | 77.9 (0.7) | 77.8 (0.6) | 77.2 (0.6) | 78.4 (0.7) | 77.2 (0.7) | 77.3 (0.6) | 82.5 (3.3) | 82.5 (2.7) |
|
| ||||||||
| SBP <60 mm Hgb | 17 (5) | 19 (5) | 16 (5) | 20 (6) | 12 (4) | 19 (6) | 4 (6) | 1 (2) |
|
| ||||||||
| Zero/no SBP obtainedb | 30 (9) | 19 (5) | 27 (8) | 22 (6) | 0 | 0 | 27 (39) | 22 (41) |
|
| ||||||||
| GCS randomizationa | 13.7 (0.1) | 13.6 (0.1) | 13.7 (0.1) | 13.7 (0.1) | 13.8 (0.1) | 13.7 (0.1) | 13.4 (0.3) | 13.3 (0.4) |
|
| ||||||||
| GCS randomization categoryb | ||||||||
|
| ||||||||
| ≤5 | 4 (1) | 2 (<1) | 4 (1) | 2 (<1) | 0 | 0 | 4 (6) | 2 (4) |
|
| ||||||||
| 6–8 | 17 (5) | 18 (5) | 18 (5) | 17 (5) | 15 (5) | 17 (5) | 2 (3) | 1 (2) |
|
| ||||||||
| 9–12 | 35 (10) | 49 (13) | 34 (10) | 50 (14) | 28 (10) | 40 (13) | 7 (10) | 9 (17) |
|
| ||||||||
| 13–15 | 294 (84) | 295 (81) | 293 (84) | 296 (81) | 236 (85) | 254 (82) | 58 (82) | 41 (77) |
|
| ||||||||
| Hb at randomization (g/dL)a,c | 13.2 (0.2) | 13.0 (0.2) | 13.2 (0.2) | 13.0 (0.2) | 13.3 (0.2) | 13.0 (0.2) | 12.8 (0.6) | 12.7 (0.7) |
|
| ||||||||
| PT at randomization (s)a | 29.4 (2.6)d | 20.9 (1.7) | 29.8 (2.6)d | 20.0 (1.6) | 28.3 (2.8)d | 20.2 (1.7) | 37.4 (8.2) | 28.5 (7.5) |
|
| ||||||||
| aPTT at randomization (s)a | 67.4 (7.3)d | 46.6 (4.4) | 68.6 (7.2)d | 44.3 (4.2) | 63.8 (7.7)d | 43.1 (4.1) | 92.6 (22.0) | 80.1 (24.0) |
|
| ||||||||
| Hb at ED admission (g/dL)a,b | 12.3 (0.1)d | 11.5 (0.2) | 12.3 (0.1)d | 11.5 (0.2) | 12.5 (0.2)d | 11.4 (0.2) | 11.6 (0.4) | 11.8 (0.4) |
|
| ||||||||
| PT at ED admission (s)a | 20.7 (1.2) | 21.0 (1.3) | 20.7 (1.2) | 20.9 (1.3) | 20.1 (1.3) | 21.0 (1.4) | 23.4 (3.1) | 20.3 (2.7) |
|
| ||||||||
| aPTT at ED admission (s)a | 49.4 (3.8) | 49.3 (4.1) | 49.3 (3.7) | 49.4 (4.1) | 46.0 (3.9) | 49.3 (4.5) | 63.2 (10.1) | 49.0 (9.2) |
Research board approved the informed consent document and procedures. Additional protection of the rights and welfare of the subjects include community consultation, public disclosure, and establishment of an independent data monitoring committee. Consent to continue the study is obtained from the patient as soon as possible.
Abbreviations: aRTT, Activated partial thromboplastin time; ED, Emergency department; PT, Prothrombin time.
a
Values are expressed as mean (SE).
b
Values are expressed as n (%); percentages are based on the number of patients in each treatment group divided by number of patients who have nonmissing values.
c
To convert to g/L, multiply by 0.1.
d
P<0.05 compared with Control.
Data from Moore EE, Moore FA, Fabian TC, et al. Human polymerized hemoglobin for the treatment of hemorrhagic shock when blood is unavailable: the USA Multicenter Trial. J Am Coll Surg 2009;208:1–13.