Holst, Lars B2; Haase, Nicolai2; Wetterslev, Jørn2; Wernerman, Jan2; Guttormsen, Anne B2; Karlsson, Sari2; Johansson, Pär I2; Aneman, Anders2; Vang, Marianne L2; Winding, Robert2; Nebrich, Lars2; Nibro, Helle L2; Rasmussen, Bodil S2; Lauridsen, Johnny R M2; Nielsen, Jane S2; Oldner, Anders2; Pettilä, Ville2; Cronhjort, Maria B2; Andersen, Lasse H2; Pedersen, Ulf G2; Reiter, Nanna2; Wiis, Jørgen2; White, Jonathan O2; Russell, Lene2; Thornberg, Klaus J2; Hjortrup, Peter B2; Müller, Rasmus G2; Møller, Morten H2; Steensen, Morten2; Tjäder, Inga2; Kilsand, Kristina2; Odeberg-Wernerman, Suzanne2; Sjøbø, Brit2; Bundgaard, Helle2; Thyø, Maria A2; Lodahl, David2; Mærkedahl, Rikke2; Albeck, Carsten2; Illum, Dorte2; Kruse, Mary2; Winkel, Per2; Perner, Anders3
1 Department of Clinical Medicine, Department of Clinical Medicine, Faculty of Health and Medical Sciences, Københavns Universitet2 unknown3 Department of Clinical Medicine, Department of Clinical Medicine, Faculty of Health and Medical Sciences, Københavns Universitet
BACKGROUND: Blood transfusions are frequently given to patients with septic shock. However, the benefits and harms of different hemoglobin thresholds for transfusion have not been established. METHODS: In this multicenter, parallel-group trial, we randomly assigned patients in the intensive care unit (ICU) who had septic shock and a hemoglobin concentration of 9 g per deciliter or less to receive 1 unit of leukoreduced red cells when the hemoglobin level was 7 g per deciliter or less (lower threshold) or when the level was 9 g per deciliter or less (higher threshold) during the ICU stay. The primary outcome measure was death by 90 days after randomization. RESULTS: We analyzed data from 998 of 1005 patients (99.3%) who underwent randomization. The two intervention groups had similar baseline characteristics. In the ICU, the lower-threshold group received a median of 1 unit of blood (interquartile range, 0 to 3) and the higher-threshold group received a median of 4 units (interquartile range, 2 to 7). At 90 days after randomization, 216 of 502 patients (43.0%) assigned to the lower-threshold group, as compared with 223 of 496 (45.0%) assigned to the higher-threshold group, had died (relative risk, 0.94; 95% confidence interval, 0.78 to 1.09; P=0.44). The results were similar in analyses adjusted for risk factors at baseline and in analyses of the per-protocol populations. The numbers of patients who had ischemic events, who had severe adverse reactions, and who required life support were similar in the two intervention groups. CONCLUSIONS: Among patients with septic shock, mortality at 90 days and rates of ischemic events and use of life support were similar among those assigned to blood transfusion at a higher hemoglobin threshold and those assigned to blood transfusion at a lower threshold; the latter group received fewer transfusions. (Funded by the Danish Strategic Research Council and others; TRISS ClinicalTrials.gov number, NCT01485315.).
New England Journal of Medicine, 2014, Vol 371, Issue 15, p. 1381-91