Overall ( n = 162) | rhTM group ( n = 68) | Control group ( n = 94) | P valuea | |
---|---|---|---|---|
Patient characteristics | ||||
Age (years)b | 69 (59 to 76) | 69 (61 to 76) | 70 (57 to 77) | 0.953 |
Male sexb | 93 (57%) | 36 (53%) | 57 (61%) | 0.339 |
Illness severity | ||||
APACHE II scoreb | 23 (19 to 29) | 25 (21 to 32) | 22 (18 to 27) | 0.008 |
SOFA scoreb | 11 (9 to 13) | 12 (9 to 13) | 11 (8 to 12) | 0.029 |
Number of dysfunctional organsb | 4 (3 to 5) | 4 (3 to 5) | 4 (3 to 5) | 0.383 |
Positive blood cultureb | 72 (44%) | 41 (60%) | 31 (33%) | 0.001 |
Coagulation parameters | ||||
Platelet count (/mm3) | 4.9 (2.7 to 6.5) | 4.4 (2.6 to 6.4) | 5.3 (2.8 to 6.6) | 0.081 |
PT-INR | 1.40 (1.23 to 1.70) | 1.40 (1.20 to 1.67) | 1.50 (1.30 to 1.78) | 0.169 |
FDP (μg/ml) | 22.3 (11.0 to 55.5) | 24.6 (13.2 to 60.0) | 20.3 (10.2 to 48.9) | 0.380 |
Fibrinogen level (mg/dl) | 350 (224 to 495) | 357 (225 to 553) | 328 (213 to 456) | 0.231 |
JAAM DIC scoreb | 6 (5 to 8) | 6 (5 to 8) | 6 (5 to 8) | 0.555 |
ISTH DIC score | 4 (3 to 5) | 4 (4 to 5) | 4 (3 to 5) | 0.457 |
Organ failure | ||||
Respiratoryb | 114 (70%) | 54 (79%) | 60 (64%) | 0.037 |
Circulatory | 134 (83%) | 57 (84%) | 77 (82%) | 0.835 |
Kidney | 86 (53%) | 37 (54%) | 49 (52%) | 0.873 |
Metabolic | 96 (59%) | 40 (59%) | 56 (60%) | 1.000 |
Hematologic | 162 (100%) | 68 (100%) | 94 (100%) | 1.000 |
Time from severe sepsis onset to study entryb | 0.689 | |||
Early (≤48 hours) | 114 (70%) | 49 (72%) | 65 (69%) | |
Late (>48 hours) | 48 (30%) | 19 (28%) | 29 (31%) | |
Co-morbidities | ||||
Diabetesb | 32 (20%) | 17 (25%) | 15 (16%) | 0.167 |
Hypertension | 38 (24%) | 18 (27%) | 20 (21%) | 0.458 |
Hemodialysis | 9 (6%) | 2 (3%) | 7 (7%) | 0.306 |
Immunosuppressionb | 19 (12%) | 11 (16%) | 8 (9%) | 0.146 |
Malignant disease | 12 (7%) | 5 (7%) | 7 (7%) | 1.000 |
Infection siteb | 0.100c | |||
Lung | 32 (20%) | 10 (15%) | 22 (23%) | |
Abdomen | 62 (38%) | 23 (34%) | 39 (42%) | |
Soft tissue | 31 (19%) | 13 (19%) | 18 (19%) | |
Urinary tract | 21 (13%) | 14 (21%) | 7 (7%) | |
Other/unknown | 16 (10%) | 8 (12%) | 8 (9%) | |
Therapeutic interventions | ||||
Vasopressor | 131 (81%) | 57 (84%) | 74 (79%) | 0.429 |
Steroid | 49 (30%) | 16 (24%) | 33 (35%) | 0.123 |
Heparin/heparinoidb | 18 (11%) | 4 (6%) | 14 (15%) | 0.081 |
Antithrombinb | 16 (10%) | 9 (13%) | 7 (7%) | 0.288 |
Renal replacement therapy | 48 (30%) | 20 (29%) | 28 (30%) | 1.000 |
Emergency operationb | 63 (39%) | 20 (29%) | 43 (46%) | 0.050 |