TY - JOUR
T1 - Lower versus Higher Hemoglobin Threshold for Transfusion in Septic Shock
AU - Holst, Lars B
AU - Haase, Nicolai
AU - Wetterslev, Jørn
AU - Wernerman, Jan
AU - Guttormsen, Anne B
AU - Karlsson, Sari
AU - Johansson, Pär I
AU - Aneman, Anders
AU - Vang, Marianne L
AU - Winding, Robert
AU - Nebrich, Lars
AU - Nibro, Helle Lykkeskov
AU - Rasmussen, Bodil S
AU - Lauridsen, Johnny René Meilstrup
AU - Nielsen, Jane S
AU - Oldner, Anders
AU - Pettilä, Ville
AU - Cronhjort, Maria B
AU - Andersen, Lasse H
AU - Gøttrup Pedersen, Ulf
AU - Reiter, Nanna
AU - Wiis, Jørgen
AU - White, Jonathan O
AU - Russell, Lene
AU - Thornberg, Klaus J
AU - Hjortrup, Peter B
AU - Müller, Rasmus G
AU - Møller, Morten H
AU - Steensen, Morten
AU - Tjäder, Inga
AU - Kilsand, Kristina
AU - Odeberg-Wernerman, Suzanne
AU - Sjøbø, Brit
AU - Bundgaard, Helle M.H.
AU - Thyø, Maria A
AU - Lodahl, David
AU - Mærkedahl, Rikke
AU - Albeck, Carsten
AU - Illum, Dorte
AU - Kruse, Mary
AU - Winkel, Per
AU - Perner, Anders
AU - the TRISS Trial Group and the Scandinavian Critical Care Trials Group
PY - 2014/10/1
Y1 - 2014/10/1
N2 - 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 .).
AB - 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 .).
U2 - 10.1056/NEJMoa1406617
DO - 10.1056/NEJMoa1406617
M3 - Journal article
C2 - 25270275
VL - 371
SP - 1381
EP - 1391
JO - New England Journal of Medicine
JF - New England Journal of Medicine
SN - 0028-4793
IS - 15
ER -