Lower versus Higher Hemoglobin Threshold for Transfusion in Septic Shock

Lars B Holst; 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

doi:10.1056/nejmoa1406617

Lower versus Higher Hemoglobin Threshold for Transfusion in Septic Shock

Lars B Holst, 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 PedersenNanna 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

Department of Clinical Medicine

515 Citations (Scopus)

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.

Original language	English
Journal	New England Journal of Medicine
Volume	371
Issue number	15
Pages (from-to)	1381-91
Number of pages	11
ISSN	0028-4793
DOIs	https://doi.org/10.1056/nejmoa1406617
Publication status	Published - 9 Oct 2014

Keywords

Aged
Erythrocyte Transfusion
Female
Hemoglobins
Humans
Intensive Care Units
Ischemia
Kaplan-Meier Estimate
Male
Middle Aged
Myocardial Ischemia
Risk
Shock, Septic
Single-Blind Method

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10.1056/nejmoa1406617

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Holst, L. B., Haase, N., Wetterslev, J., Wernerman, J., Guttormsen, A. B., Karlsson, S., Johansson, P. I., Aneman, A., Vang, M. L., Winding, R., Nebrich, L., Nibro, H. L., Rasmussen, B. S., Lauridsen, J. R. M., Nielsen, J. S., Oldner, A., Pettilä, V., Cronhjort, M. B., Andersen, L. H., ... TRISS Trial Group (2014). Lower versus Higher Hemoglobin Threshold for Transfusion in Septic Shock. New England Journal of Medicine, 371(15), 1381-91. https://doi.org/10.1056/nejmoa1406617

Holst, LB, Haase, N, Wetterslev, J, Wernerman, J, Guttormsen, AB, Karlsson, S, Johansson, PI, Aneman, A, Vang, ML, Winding, R, Nebrich, L, Nibro, HL, Rasmussen, BS, Lauridsen, JRM, Nielsen, JS, Oldner, A, Pettilä, V, Cronhjort, MB, Andersen, LH, Pedersen, UG, Reiter, N, Wiis, J, White, JO, Russell, L, Thornberg, KJ, Hjortrup, PB, Müller, RG, Møller, MH, Steensen, M, Tjäder, I, Kilsand, K, Odeberg-Wernerman, S, Sjøbø, B, Bundgaard, H, Thyø, MA, Lodahl, D, Mærkedahl, R, Albeck, C, Illum, D, Kruse, M, Winkel, P, Perner, A & TRISS Trial Group 2014, 'Lower versus Higher Hemoglobin Threshold for Transfusion in Septic Shock', New England Journal of Medicine, vol. 371, no. 15, pp. 1381-91. https://doi.org/10.1056/nejmoa1406617

@article{84975654cb13472f8084e45e7ef654eb,

title = "Lower versus Higher Hemoglobin Threshold for Transfusion in Septic Shock",

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.",

keywords = "Aged, Erythrocyte Transfusion, Female, Hemoglobins, Humans, Intensive Care Units, Ischemia, Kaplan-Meier Estimate, Male, Middle Aged, Myocardial Ischemia, Risk, Shock, Septic, Single-Blind Method",

author = "Holst, {Lars B} and Nicolai Haase and J{\o}rn Wetterslev and Jan Wernerman and Guttormsen, {Anne B} and Sari Karlsson and Johansson, {P{\"a}r I} and Anders Aneman and Vang, {Marianne L} and Robert Winding and Lars Nebrich and Nibro, {Helle L} and Rasmussen, {Bodil S} and Lauridsen, {Johnny R M} and Nielsen, {Jane S} and Anders Oldner and Ville Pettil{\"a} and Cronhjort, {Maria B} and Andersen, {Lasse H} and Pedersen, {Ulf G} and Nanna Reiter and J{\o}rgen Wiis and White, {Jonathan O} and Lene Russell and Thornberg, {Klaus J} and Hjortrup, {Peter B} and M{\"u}ller, {Rasmus G} and M{\o}ller, {Morten H} and Morten Steensen and Inga Tj{\"a}der and Kristina Kilsand and Suzanne Odeberg-Wernerman and Brit Sj{\o}b{\o} and Helle Bundgaard and Thy{\o}, {Maria A} and David Lodahl and Rikke M{\ae}rkedahl and Carsten Albeck and Dorte Illum and Mary Kruse and Per Winkel and Anders Perner and {TRISS Trial Group}",

year = "2014",

month = oct,

day = "9",

doi = "10.1056/nejmoa1406617",

language = "English",

volume = "371",

pages = "1381--91",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachusetts Medical Society",

number = "15",

}

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 L

AU - Rasmussen, Bodil S

AU - Lauridsen, Johnny R M

AU - Nielsen, Jane S

AU - Oldner, Anders

AU - Pettilä, Ville

AU - Cronhjort, Maria B

AU - Andersen, Lasse H

AU - Pedersen, Ulf G

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

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 - TRISS Trial Group

PY - 2014/10/9

Y1 - 2014/10/9

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.

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.

KW - Aged

KW - Erythrocyte Transfusion

KW - Female

KW - Hemoglobins

KW - Humans

KW - Intensive Care Units

KW - Ischemia

KW - Kaplan-Meier Estimate

KW - Male

KW - Middle Aged

KW - Myocardial Ischemia

KW - Risk

KW - Shock, Septic

KW - Single-Blind Method

U2 - 10.1056/nejmoa1406617

DO - 10.1056/nejmoa1406617

M3 - Journal article

C2 - 25270275

SN - 0028-4793

VL - 371

SP - 1381

EP - 1391

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 15

ER -

Lower versus Higher Hemoglobin Threshold for Transfusion in Septic Shock

Abstract

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