Lower versus Higher Hemoglobin Threshold for Transfusion in Septic Shock.
Holst, Lars B. M.D.; Haase, Nicolai M.D., Ph.D.; Wetterslev, Jorn M.D., Ph.D.; Wernerman, Jan M.D., Ph.D.; Guttormsen, Anne B. M.D., Ph.D.; Karlsson, Sari M.D., Ph.D.; Johansson, Par I. M.D., Ph.D.; Aneman, Anders M.D., Ph.D.; Vang, Marianne L. M.D.; Winding, Robert M.D.; Nebrich, Lars M.D.; Nibro, Helle L. M.D., Ph.D.; Rasmussen, Bodil S. M.D., Ph.D.; Lauridsen, Johnny R.M. M.D.; Nielsen, Jane S. M.D.; Oldner, Anders M.D., Ph.D.; Pettila, Ville M.D., Ph.D.; Cronhjort, Maria B. M.D.; Andersen, Lasse H. M.D.; Pedersen, Ulf G. M.D.; Reiter, Nanna M.D.; Wiis, Jorgen M.D.; White, Jonathan O. M.D.; Russell, Lene M.D.; Thornberg, Klaus J. M.D.; Hjortrup, Peter B. M.D.; Muller, Rasmus G. M.D.; Moller, Morten H. M.D., Ph.D.; Steensen, Morten M.D.; Tjader, Inga M.D., Ph.D.; Kilsand, Kristina R.N.; Odeberg-Wernerman, Suzanne M.D., Ph.D.; Sjobo, Brit R.N.; Bundgaard, Helle M.D., Ph.D.; Thyo, Maria A. M.D.; Lodahl, David M.D.; Maerkedahl, Rikke M.D.; Albeck, Carsten M.D.; Illum, Dorte M.D.; Kruse, Mary M.D.; Winkel, Per M.D., D.M.Sci.; Perner, Anders M.D., Ph.D.; the TRISS Trial Group and the Scandinavian Critical Care Trials Group *
[Article]
New England Journal of Medicine.
371(15):1381-1391, October 9, 2014.
(Format: HTML, PDF)
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.)
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