Table 1.
Characteristics and clinical course of patients with sepsis in the derivation and validation cohorts
| Variables | Test set of the derivation cohort (n = 1108) |
Validation cohort (n = 1184) |
||
|---|---|---|---|---|
| Predicted target patients n = 118 |
Patients with rhTM target phenotype n = 85 |
Predicted target patients n = 142 |
Patients with rhTM target phenotype n = 108 |
|
| Age, median (IQR) | 71 (56, 79) | 70 (55, 79) | 73 (64, 82) | 73 (64, 82) |
| Sex, female | 60 (51%) | 42 (49%) | 61 (43%) | 45 (42%) |
| Body weight (kg), median (IQR) | 54 (49, 63) | 55 (49, 64) | 55.0 (47.0, 65.0) | 53.0 (46.5, 60.5) |
| Infection site | ||||
| Catheter-related | 2 (2%) | 0 (0%) | 7 (5%) | 6 (6%) |
| Bone/soft tissue | 10 (8%) | 7 (8%) | 11 (8%) | 7 (6%) |
| Cardiovascular | 5 (4%) | 5 (6%) | 5 (4%) | 5 (5%) |
| Central nervous system | 3 (3%) | 3 (4%) | 2 (1%) | 2 (2%) |
| Urinary tract | 28 (24%) | 21 (25%) | 39 (27%) | 31 (29%) |
| Lung/thoracic | 16 (14%) | 13 (15%) | 24 (17%) | 19 (18%) |
| Abdomen | 33 (28%) | 19 (22%) | 38 (27%) | 25 (23%) |
| Other/unknown | 21 (18%) | 17 (20%) | 16 (11%) | 13 (20%) |
| APACHE II, median (IQR) | 28 (21, 34) | 27 (21, 34) | 27 (22, 33) | 27 (22, 32) |
| SIRS score, median (IQR) | 3 (3, 4) | 3 (3, 4) | 3 (3, 4) | 3 (3, 4) |
| SOFA scores | 13 (10, 16) | 13 (10, 16) | 13 (11, 13) | 11 (9, 14) |
| Lab data | ||||
| White blood cell (103/μL), median (IQR) | 11.5 (2.7, 20.3) | 12.4 (2.7, 20.7) | 11.0 (6.1, 20.1) | 10.8 (6.3, 20.0) |
| Platelet (103/μL), median (IQR) | 54 (29, 99) | 47 (26, 76) | 73 (42, 122) | 68 (41, 121) |
| PT-INR, median (IQR) | 1.7 (1.4, 2.1) | 1.7 (1.4, 2.1) | 1.5 (1.3, 1.7) | 1.5 (1.3, 1.7) |
| Fibrinogen (mg/mL), median (IQR) | 237 (141, 328) | 220 (130, 311) | 269 (153, 378) | 277 (154, 381) |
| FDP (μg/mL), median (IQR) | 98 (68, 224) | 127 (80, 299) | 107 (73, 188) | 121 (93, 245) |
| D-dimer (μg/mL), median (IQR) | 42 (31, 94) | 51 (34, 119) | 48 (32, 83) | 60 (40, 106) |
| Antithrombin (%), median (IQR) | 51 (42, 60) | 50 (42, 58) | 54 (48, 65) | 55 (49, 66) |
| Lactate (mmol/L), median (IQR) | 6 (3, 10) | 6 (4, 10) | 5 (3, 7) | 5 (3, 7) |
| Patients who met the inclusion criteria for the SCARLET trial* | ||||
| Coagulopathy | 29 (25%) | 23 (27%) | 32 (23%) | 33 (31%) |
| Coagulopathy and respiratory/cardiovascular dysfunction | 25 (21%) | 21 (25%) | 27 (19%) | 20 (16%) |
| Management | ||||
| rhTM | 52 (44%) | 41 (48%) | 55 (39%) | 44 (44%) |
| Vasopressor use | 105 (89%) | 77 (91%) | 103 (73%) | 77 (71%) |
| Renal replacement therapy | 51 (43%) | 40 (47%) | 23 (16%) | 16 (15%) |
| Steroids | 35 (30%) | 26 (31%) | 65 (48%) | 48 (44%) |
| Intravenous immunoglobulin | 58 (49%) | 40 (47%) | 50 (35%) | 18 (17%) |
| Antithrombin | 59 (50%) | 41 (48%) | 28 (20%) | 22 (20%) |
| Prognosis | ||||
| 28-day death | 48 (41%) | 36 (42%) | 40 (28%) | 24 (25%) |
| In-hospital death | 62 (53%) | 47 (55%) | 47 (33%) | 28 (28%) |
APACHE, Acute Physiology and Chronic Health Evaluation; FDP, fibrinogen/fibrin degradation product; IQR, interquartile range; PT-INR, prothrombin time-international normalised ratio; SIRS, systemic inflammatory response syndrome; SOFA, Sequential Organ Failure Assessment; and WBC, white blood cells
Five coagulation markers (in bold) were used for prediction
*Defined as patients with (1) coagulopathy (PT-INR > 1.4 and platelet count 30 to 150 × 109/L) and (2) vasopressor use or mechanical ventilation use