Liberal versus restrictive transfusion strategy in critically iII oncologic patients: The transfusion requirements in critically iII oncologic patients randomized controlled trial

FS Bergamin, JP Almeida, G Landoni, FRBG Galas, JT Fukushima, E Fominskiy, CHL Park, EA Osawa, MPE Diz, GQ Oliveira, RA Franco, RE Nakamura, EM Almeida, E Abdala, MP Freire, RK Filho, JOC Auler, LA Hajjar

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Abstract

Objective: To assess whether a restrictive strategy of RBC transfusion reduces 28-day mortality when compared with a liberal strategy in cancer patients with septic shock. Design: Single center, randomized, double-blind controlled trial. Setting: Teaching hospital. Patients: Adult cancer patients with septic shock in the first 6 hours of ICU admission. Interventions: Patients were randomized to the liberal (hemoglobin threshold, <9 g/dL) or to the restrictive strategy (hemoglobin threshold, <7 g/dL) of RBC transfusion during ICU stay. Measurements and Main Results: Patients were randomized to the liberal (n = 149) or to the restrictive transfusion strategy (n = 151) group. Patients in the liberal group received more RBC units than patients in the restrictive group (1 [0-3] vs 0 [0-2] unit; p <0.001). At 28 days after randomization, mortality rate in the liberal group (primary endpoint of the study) was 45% (67 patients) versus 56% (84 patients) in the restrictive group (hazard ratio, 0.74; 95% CI, 0.53-1.04; p = 0.08) with no differences in ICU and hospital length of stay. At 90 days after randomization, mortality rate in the liberal group was lower (59% vs 70%) than in the restrictive group (hazard ratio, 0.72; 95% CI, 0.53-0.97; p = 0.03). Conclusions: We observed a survival trend favoring a liberal transfusion strategy in patients with septic shock when compared with the restrictive strategy. These results went in the opposite direction of the a priori hypothesis and of other trials in the field and need to be confirmed. © 2017 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.
Original languageEnglish
Pages (from-to)766-773
Number of pages8
JournalCritical Care Medicine
Volume45
Issue number5
DOIs
Publication statusPublished - 2017

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Randomized Controlled Trials
Septic Shock
Random Allocation
Mortality
Length of Stay
Hemoglobins
Teaching Hospitals
Neoplasms
Survival
Health

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Liberal versus restrictive transfusion strategy in critically iII oncologic patients: The transfusion requirements in critically iII oncologic patients randomized controlled trial. / Bergamin, FS; Almeida, JP; Landoni, G; Galas, FRBG; Fukushima, JT; Fominskiy, E; Park, CHL; Osawa, EA; Diz, MPE; Oliveira, GQ; Franco, RA; Nakamura, RE; Almeida, EM; Abdala, E; Freire, MP; Filho, RK; Auler, JOC; Hajjar, LA.

In: Critical Care Medicine, Vol. 45, No. 5, 2017, p. 766-773.

Research output: Contribution to journalArticle

Bergamin, FS, Almeida, JP, Landoni, G, Galas, FRBG, Fukushima, JT, Fominskiy, E, Park, CHL, Osawa, EA, Diz, MPE, Oliveira, GQ, Franco, RA, Nakamura, RE, Almeida, EM, Abdala, E, Freire, MP, Filho, RK, Auler, JOC & Hajjar, LA 2017, 'Liberal versus restrictive transfusion strategy in critically iII oncologic patients: The transfusion requirements in critically iII oncologic patients randomized controlled trial', Critical Care Medicine, vol. 45, no. 5, pp. 766-773. https://doi.org/10.1097/CCM.0000000000002283
Bergamin, FS ; Almeida, JP ; Landoni, G ; Galas, FRBG ; Fukushima, JT ; Fominskiy, E ; Park, CHL ; Osawa, EA ; Diz, MPE ; Oliveira, GQ ; Franco, RA ; Nakamura, RE ; Almeida, EM ; Abdala, E ; Freire, MP ; Filho, RK ; Auler, JOC ; Hajjar, LA. / Liberal versus restrictive transfusion strategy in critically iII oncologic patients: The transfusion requirements in critically iII oncologic patients randomized controlled trial. In: Critical Care Medicine. 2017 ; Vol. 45, No. 5. pp. 766-773.
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abstract = "Objective: To assess whether a restrictive strategy of RBC transfusion reduces 28-day mortality when compared with a liberal strategy in cancer patients with septic shock. Design: Single center, randomized, double-blind controlled trial. Setting: Teaching hospital. Patients: Adult cancer patients with septic shock in the first 6 hours of ICU admission. Interventions: Patients were randomized to the liberal (hemoglobin threshold, <9 g/dL) or to the restrictive strategy (hemoglobin threshold, <7 g/dL) of RBC transfusion during ICU stay. Measurements and Main Results: Patients were randomized to the liberal (n = 149) or to the restrictive transfusion strategy (n = 151) group. Patients in the liberal group received more RBC units than patients in the restrictive group (1 [0-3] vs 0 [0-2] unit; p <0.001). At 28 days after randomization, mortality rate in the liberal group (primary endpoint of the study) was 45{\%} (67 patients) versus 56{\%} (84 patients) in the restrictive group (hazard ratio, 0.74; 95{\%} CI, 0.53-1.04; p = 0.08) with no differences in ICU and hospital length of stay. At 90 days after randomization, mortality rate in the liberal group was lower (59{\%} vs 70{\%}) than in the restrictive group (hazard ratio, 0.72; 95{\%} CI, 0.53-0.97; p = 0.03). Conclusions: We observed a survival trend favoring a liberal transfusion strategy in patients with septic shock when compared with the restrictive strategy. These results went in the opposite direction of the a priori hypothesis and of other trials in the field and need to be confirmed. {\circledC} 2017 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.",
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TY - JOUR

T1 - Liberal versus restrictive transfusion strategy in critically iII oncologic patients: The transfusion requirements in critically iII oncologic patients randomized controlled trial

AU - Bergamin, FS

AU - Almeida, JP

AU - Landoni, G

AU - Galas, FRBG

AU - Fukushima, JT

AU - Fominskiy, E

AU - Park, CHL

AU - Osawa, EA

AU - Diz, MPE

AU - Oliveira, GQ

AU - Franco, RA

AU - Nakamura, RE

AU - Almeida, EM

AU - Abdala, E

AU - Freire, MP

AU - Filho, RK

AU - Auler, JOC

AU - Hajjar, LA

PY - 2017

Y1 - 2017

N2 - Objective: To assess whether a restrictive strategy of RBC transfusion reduces 28-day mortality when compared with a liberal strategy in cancer patients with septic shock. Design: Single center, randomized, double-blind controlled trial. Setting: Teaching hospital. Patients: Adult cancer patients with septic shock in the first 6 hours of ICU admission. Interventions: Patients were randomized to the liberal (hemoglobin threshold, <9 g/dL) or to the restrictive strategy (hemoglobin threshold, <7 g/dL) of RBC transfusion during ICU stay. Measurements and Main Results: Patients were randomized to the liberal (n = 149) or to the restrictive transfusion strategy (n = 151) group. Patients in the liberal group received more RBC units than patients in the restrictive group (1 [0-3] vs 0 [0-2] unit; p <0.001). At 28 days after randomization, mortality rate in the liberal group (primary endpoint of the study) was 45% (67 patients) versus 56% (84 patients) in the restrictive group (hazard ratio, 0.74; 95% CI, 0.53-1.04; p = 0.08) with no differences in ICU and hospital length of stay. At 90 days after randomization, mortality rate in the liberal group was lower (59% vs 70%) than in the restrictive group (hazard ratio, 0.72; 95% CI, 0.53-0.97; p = 0.03). Conclusions: We observed a survival trend favoring a liberal transfusion strategy in patients with septic shock when compared with the restrictive strategy. These results went in the opposite direction of the a priori hypothesis and of other trials in the field and need to be confirmed. © 2017 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.

AB - Objective: To assess whether a restrictive strategy of RBC transfusion reduces 28-day mortality when compared with a liberal strategy in cancer patients with septic shock. Design: Single center, randomized, double-blind controlled trial. Setting: Teaching hospital. Patients: Adult cancer patients with septic shock in the first 6 hours of ICU admission. Interventions: Patients were randomized to the liberal (hemoglobin threshold, <9 g/dL) or to the restrictive strategy (hemoglobin threshold, <7 g/dL) of RBC transfusion during ICU stay. Measurements and Main Results: Patients were randomized to the liberal (n = 149) or to the restrictive transfusion strategy (n = 151) group. Patients in the liberal group received more RBC units than patients in the restrictive group (1 [0-3] vs 0 [0-2] unit; p <0.001). At 28 days after randomization, mortality rate in the liberal group (primary endpoint of the study) was 45% (67 patients) versus 56% (84 patients) in the restrictive group (hazard ratio, 0.74; 95% CI, 0.53-1.04; p = 0.08) with no differences in ICU and hospital length of stay. At 90 days after randomization, mortality rate in the liberal group was lower (59% vs 70%) than in the restrictive group (hazard ratio, 0.72; 95% CI, 0.53-0.97; p = 0.03). Conclusions: We observed a survival trend favoring a liberal transfusion strategy in patients with septic shock when compared with the restrictive strategy. These results went in the opposite direction of the a priori hypothesis and of other trials in the field and need to be confirmed. © 2017 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.

U2 - 10.1097/CCM.0000000000002283

DO - 10.1097/CCM.0000000000002283

M3 - Article

VL - 45

SP - 766

EP - 773

JO - Critical Care Medicine

JF - Critical Care Medicine

SN - 0090-3493

IS - 5

ER -