Phase 3 trials of new anticoagulants in severe sepsis
. | . | . | . | . | . | . | Main results . | . | |
|---|---|---|---|---|---|---|---|---|---|
| Anti-coagulant . | Study . | No. of patients . | Population . | Regimen . | Control . | Outcome measure . | Outcome measure . | Major bleeding . | |
| r-TFPI | Abraham et al10 | 1754 | Severe sepsis with INR ≥ 1.2 | IV infusion 0.025 mg/kg/h, × 96 h | Placebo | All-cause mortality at 28 d | r-TFPI: 301/880 (34.2%) | r-TFPI: 57/880 (6.5%) | |
| Placebo: 296/874 (33.9%) | Placebo: 42/874 (4.8%) | ||||||||
| NS | NS | ||||||||
| Activated protein C | Bernard et al11 | 1690 | Severe sepsis | IV infusion 24 μg/kg/h × 96 h | Placebo | All-cause mortality at 28 d | APC: 210/850 (24.7%) | APC: 30/850 (3.5%) | |
| Placebo: 259/840 (30.8%) | Placebo: 17/840 (2.0%) | ||||||||
| P = .005 | NS | ||||||||
. | . | . | . | . | . | . | Main results . | . | |
|---|---|---|---|---|---|---|---|---|---|
| Anti-coagulant . | Study . | No. of patients . | Population . | Regimen . | Control . | Outcome measure . | Outcome measure . | Major bleeding . | |
| r-TFPI | Abraham et al10 | 1754 | Severe sepsis with INR ≥ 1.2 | IV infusion 0.025 mg/kg/h, × 96 h | Placebo | All-cause mortality at 28 d | r-TFPI: 301/880 (34.2%) | r-TFPI: 57/880 (6.5%) | |
| Placebo: 296/874 (33.9%) | Placebo: 42/874 (4.8%) | ||||||||
| NS | NS | ||||||||
| Activated protein C | Bernard et al11 | 1690 | Severe sepsis | IV infusion 24 μg/kg/h × 96 h | Placebo | All-cause mortality at 28 d | APC: 210/850 (24.7%) | APC: 30/850 (3.5%) | |
| Placebo: 259/840 (30.8%) | Placebo: 17/840 (2.0%) | ||||||||
| P = .005 | NS | ||||||||
r-TFPI indicates recombinant tissue factor pathway inhibitor; IV, intravenous; NS, not significant.