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Liberal Versus Restrictive Transfusion Strategy in Critically Ill Oncologic Patients: The Transfusion Requirements in Critically Ill Oncologic Patients Randomized Controlled Trial*

Bergamin, Fabricio S. MD1; Almeida, Juliano P. MD, PhD1; Landoni, Giovanni MD2; Galas, Filomena R. B. G. MD, PhD1; Fukushima, Julia T. MSc1; Fominskiy, Evgeny MD, PhD2; Park, Clarice H. L. MD1; Osawa, Eduardo A. MD, PhD1; Diz, Maria P. E. MD, PhD1; Oliveira, Gisele Q. MD1; Franco, Rafael A. MD1; Nakamura, Rosana E. MD1; Almeida, Elisangela M. MD1; Abdala, Edson MD, PhD3; Freire, Maristela P. MD, PhD3; Filho, Roberto K. MD, PhD4; Auler, Jose Otavio C. Jr MD, PhD1; Hajjar, Ludhmila A. MD, PhD1,4

doi: 10.1097/CCM.0000000000002283
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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.

1Intensive Care Unit and Department of Anesthesiology, Instituto do Cancer, Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.

2Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.

3Department of Infectious Diseases, Hospital Infection Control and Infectious Diseases Unit, Instituto do Cancer do Estado de São Paulo, Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.

4Department of Cardiopneumology, Instituto do Coracao, Hospital das Clinicas, Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.

*See also p. 908.

This study was performed at the Intensive Care Unit and Department of Anesthesiology, Instituto do Cancer, Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s website (http://journals.lww.com/ccmjournal).

Dr. Park disclosed government work. The remaining authors have disclosed that they do not have any potential conflicts of interest.

For information regarding this article, E-mail: landoni.giovanni@hsr.it

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