Table 1. Baseline characteristics and outcomes.
| Cx611 (n=41) | Placebo (n=41) | |
| Demographics | ||
| Age, years | 60.9 (11.3) | 63.4 (10.4) |
| Sex, male | 27 (65.9%) | 26 (63.4%) |
| Disease severity | ||
| Randomisation stratum | ||
| Invasive mechanical ventilation | 22 (53.7%) | 23 (56.1%) |
| Shock | 14 (34.1%) | 13 (31.7%) |
| Both | 5 (12.2%) | 5 (12.2%) |
| CURB-65 | 3 [2, 3] | 3 [2, 4] |
| APACHE II score | 20.2 (7.7) | 18.9 (6.2) |
| SOFA score* | 8 [7, 11] | 8 [7, 9] |
| Outcomes † | ||
| Any thromboembolic event‡ | 7 (17.1%) | 8 (19.5%) |
| Length of intensive care unit stay | 13 [6, 29] | 11 [6, 19] |
| Length of hospital stay | 20 [12, 44] | 19 [14, 36] |
| 28-day mortality | 8 (19.5%) | 6 (14.6%) |
Normally distributed continuous variables are listed as mean (SD); non-normally distributed continuous variables are listed as median [IQR]; categorical variables are listed as count (%).
All patients fulfilled the Sepsis-3 criteria (infection plus SOFA score of 2 or higher).
A full overview of adverse events and clinical outcomes can be found in the primary clinical report.5
Individual patients could have more than one thromboembolic event. For the Cx611 group, this included deep vein thrombosis (n=3), pulmonary embolism (n=1), cerebrovascular accident (n=2), device-related thrombosis (n=1), atrial thrombosis (n=1) and cerebral artery embolism (n=1). For the placebo group, this included deep vein thrombosis (n=5), pulmonary embolism (n=2), venous thrombosis (n=1), venous thrombosis of a limb (n=1) and jugular vein thrombosis (n=1).
APACHE-IIAcute Physiology and Chronic Health Evaluation IICURB-65confusion, blood urea nitrogen, respiratory rate, blood pressure, age 65 or olderSOFASequential Organ Failure Assessment