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Table 1 Baseline characteristics of all patients with sepsis-induced DIC untreated or treated with rhTM

From: Benefit profile of recombinant human soluble thrombomodulin in sepsis-induced disseminated intravascular coagulation: a multicenter propensity score analysis

  Overall ( n= 162) rhTM group ( n= 68) Control group ( n= 94) P value a
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
  1. APACHE, Acute Physiology and Chronic Health Evaluation; DIC, disseminated intravascular coagulation; FDP, fibrin/fibrinogen degradation products; ISTH, International Society on Thrombosis and Hemostasis; JAAM, Japanese Association for Acute Medicine; PT-INR, prothrombin time–International Normalized Ratio; rhTM, recombinant human soluble thrombomodulin; SOFA, Sequential Organ Failure Assessment. Data are expressed as group median (interquartile range) or proportion (%). a P value for rhTM-treated patients versus untreated patients. bThe 15 variables used in propensity score calculation. cOnly one P value, for site of infection, is shown because the test was performed as a chi-square test on a 2 × 5 crosstable.