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Randomized Controlled Trial
. 2014 Oct 9;371(15):1381-91.
doi: 10.1056/NEJMoa1406617. Epub 2014 Oct 1.

Lower versus higher hemoglobin threshold for transfusion in septic shock

Lars B Holst  1 , Nicolai Haase, Jørn Wetterslev, Jan Wernerman, Anne B Guttormsen, Sari Karlsson, Pär I Johansson, Anders Aneman, Marianne L Vang, Robert Winding, Lars Nebrich, Helle L Nibro, Bodil S Rasmussen, Johnny R M Lauridsen, Jane S Nielsen, Anders Oldner, Ville Pettilä, Maria B Cronhjort, Lasse H Andersen, Ulf G Pedersen, Nanna Reiter, Jørgen Wiis, Jonathan O White, Lene Russell, Klaus J Thornberg, Peter B Hjortrup, Rasmus G Müller, Morten H Møller, Morten Steensen, Inga Tjäder, Kristina Kilsand, Suzanne Odeberg-Wernerman, Brit Sjøbø, Helle Bundgaard, Maria A Thyø, David Lodahl, Rikke Mærkedahl, Carsten Albeck, Dorte Illum, Mary Kruse, Per Winkel, Anders Perner; TRISS Trial Group; Scandinavian Critical Care Trials Group
Collaborators, Affiliations
Free article
Randomized Controlled Trial

Lower versus higher hemoglobin threshold for transfusion in septic shock

Lars B Holst et al. N Engl J Med. .
Free article

Abstract

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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