Efficacy and Safety of Tifacogin (Recombinant Tissue Factor Pathway Inhibitor) in Severe Sepsis. Abraham E, Reinhart K, Opal S, Demeyer I, Doig C, Rodriguez AL, Beale R, Svoboda P, Laterre PF, Simon S,Light B, Spapen H, Stone J, Seibert A, Peckelsen C, De Deyne C, Postier R, Pettilä V, Artigas A, Percell SR, Shu V, Zwingelstein C, Tobias J, Poole L, Stolzenbach JC, Creasey AA.
Overall Study Question
These investigators compared tifacogin (recombinant tissue factor pathway inhibitor) to placebo in patients with severe sepsis.
1754 patients with severe sepsis and an elevated INR. The mean age of the patients was 62 and 42% were female. Approximately 50% had a respiratory tract infection, and the mean APACHE score at baseline was 25.
Patients were randomized in a blinded fashion to receive either tifacogin for 96 hours or placebo.
The study duration 28 days.
Serious adverse event with bleeding were increased by approximately 2-3 % in the tifacogin group.
How does this study contribute to the drug therapy of patients with severe sepsis?
This study suggests that a recombinant tissue factor pathway inhibitor has no effect on overall mortality and may increase the risk of a severe bleeding complication.