Table 1 Summary of baseline characteristics of the primary efficacy population
Variable | Alternative therapy (n = 206) | Standard therapy (n = 227) | Total (n = 433) | P-value* |
|---|---|---|---|---|
Age, mean ± SD | 61.9 ± 14.4 | 62.3 ± 16.1 | 62.1 ± 15.3 | 0.480 |
Male, n (%) | 130 (63.1) | 137 (60.4) | 267 (61.7) | 0.556 |
Caucasian, n (%) | 189 (91.7) | 204 (89.9) | 393 (90.8) | 0.172 |
European, n (%) | 144 (69.9) | 159 (70.0) | 303 (70.0) | 0.974 |
Recent surgery, n (%) | 61 (29.6) | 68 (30.0) | 129 (29.8) | 0.575 |
Number of organ dysfunctions, n (%): | 0.759 | |||
2 | 55 (26.7) | 62 (27.3) | 117 (27.0) | |
3 | 88 (42.7) | 99 (43.6) | 187 (43.2) | |
4 | 54 (26.2) | 52 (22.9) | 106 (24.5) | |
5 | 9 (4.4) | 14 (6.2) | 23 (5.3) | |
Number of organ dysfunctions, mean ± SD | 3.08 ± 0.84 | 3.08 ± 0.86 | 3.08 ± 0.85 | 0.97 |
Organ dysfunction criteria, n (%): | ||||
Cardiovascular | 199 (96.6) | 220 (96.9) | 419 (96.8) | 0.853 |
Respiratory | 175 (85.0) | 185 (81.5) | 360 (83.1) | 0.338 |
Renal | 114 (55.3) | 139 (61.2) | 253 (58.4) | 0.214 |
Hematology | 37 (18.0) | 36 (15.9) | 73 (16.9) | 0.560 |
Metabolic | 110 (53.4) | 119 (52.4) | 229 (52.9) | 0.839 |
Time of onset of 2nd OD to start of drug infusion, hr ± SD | 15.0 ± 7.0 | 15.3 ± 7.0 | 15.2 ± 7.0 | 0.810 |
Total SOFA, mean ± SD | 8.65 ± 2.70 | 8.38 ± 2.83 | 8.51 ± 2.77 | 0.657 |
APACHE II score, mean ± SD | 26.15 ± 7.31 | 26.34 ± 7.70 | 26.25 ± 7.51 | 0.854 |
DIC, average mean score ± SD | 3.95 ± 1.14 | 4.01 ± 1.16 | 3.98 ± 1.15 | 0.62 |
Use of vasopressor, n (%) | 183 (88.8) | 190 (83.7) | 373 (86.1) | 0.122 |
D-dimer level (mg/L), mean ± SD | 7.31 ± 8.47 | 8.29 ± 9.48 | 7.81 ± 9.01 | 0.222 |
Protein C level (% activity), mean ± SD | 41 ± 20 | 44 ± 19 | 43 ± 20 | 0.084 |
Central lab protein C class (%): | 0.504 | |||
Severe deficiency | 54.1 | 48.5 | 51.2 | |
Moderate deficiency | 41.1 | 47.0 | 44.2 | |
Normal† | 4.9 | 4.5 | 4.7 | |
Mechanical ventilation, n (%) | 158 (76.7) | 178 (78.4) | 336 (77.6) | 0.669 |
Medical history, n (%): | ||||
Hypertension | 93 (45.1) | 118 (52.0) | 211 (48.7) | 0.155 |
Coronary artery disease | 28 (13.6) | 36 (15.9) | 64 (14.8) | 0.372 |
Cardiomyopathy | 19 (9.2) | 21 (9.3) | 40 (9.2) | 0.878 |
Diabetes mellitus | 43 (20.9) | 66 (29.1) | 109 (25.2) | 0.089 |
Pancreatitis | 9 (4.4) | 10 (4.4) | 19 (4.4) | 0.331 |
Liver disease | 6 (2.9) | 8 (3.5) | 14 (3.2) | 0.200 |
COPD | 37 (18.0) | 34 (15.0) | 71 (16.4) | 0.136 |
Malignancy | 40 (19.4) | 50 (22.0) | 90 (20.8) | 0.290 |
Stroke | 7 (3.4) | 14 (6.2) | 21 (4.8) | 0.139 |
Thrombosis | 2 (1.0) | 13 (5.7) | 15 (3.5) | 0.009 |
Baseline medications, n (%): | ||||
Steroids for septic shock | 100 (48.5) | 108 (47.6) | 208 (48) | 0.841 |
Insulin | 106 (51.5) | 138 (60.8) | 244 (56.4) | 0.050 |
Statins | 42 (20.5) | 46 (20.3) | 88 (20.4) | 0.954 |
Prophylactic heparin | 82 (39.8) | 97 (42.7) | 179 (41.3) | 0.537 |