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Published in: Intensive Care Medicine 11/2016

01-11-2016 | Seven-Day Profile Publication

Long-term outcomes in patients with septic shock transfused at a lower versus a higher haemoglobin threshold: the TRISS randomised, multicentre clinical trial

Authors: Sofie L. Rygård, Lars B. Holst, Jørn Wetterslev, Per Winkel, Pär I. Johansson, Jan Wernerman, Anne B. Guttormsen, Sari Karlsson, Anders Perner, The TRISS Trial Group, The Scandinavian Critical Care Trials Group

Published in: Intensive Care Medicine | Issue 11/2016

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Abstract

Purpose

We assessed the predefined long-term outcomes in patients randomised in the Transfusion Requirements in Septic Shock (TRISS) trial.

Methods

In 32 Scandinavian ICUs, we randomised 1005 patients with septic shock and haemoglobin of 9 g/dl or less to receive single units of leuko-reduced red cells when haemoglobin level was 7 g/dl or less (lower threshold) or 9 g/dl or less (higher threshold) during ICU stay. We assessed mortality rates 1 year after randomisation and again in all patients at time of longest follow-up in the intention-to-treat population (n = 998) and health-related quality of life (HRQoL) 1 year after randomisation in the Danish patients only (n = 777).

Results

Mortality rates in the lower- versus higher-threshold group at 1 year were 53.5 % (268/501 patients) versus 54.6 % (271/496) [relative risk 0.97; 95 % confidence interval (CI) 0.85–1.09; P = 0.62]; at longest follow-up (median 21 months), they were 56.7 % (284/501) versus 61.0 % (302/495) (hazard ratio 0.88; 95 % CI 0.75–1.03; P = 0.12). We obtained HRQoL data at 1 year in 629 of the 777 (81 %) Danish patients, and mean differences between the lower- and higher-threshold group in scores of physical HRQoL were 0.4 (95 % CI −2.4 to 3.1; P = 0.79) and in mental HRQoL 0.5 (95 % CI −3.1 to 4.0; P = 0.79).

Conclusions

Long-term mortality rates and HRQoL did not differ in patients with septic shock and anaemia who were transfused at a haemoglobin threshold of 7 g/dl versus a threshold of 9 g/dl. We may reject a more than 3 % increased hazard of death in the lower- versus higher-threshold group at the time of longest follow-up.
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Metadata
Title
Long-term outcomes in patients with septic shock transfused at a lower versus a higher haemoglobin threshold: the TRISS randomised, multicentre clinical trial
Authors
Sofie L. Rygård
Lars B. Holst
Jørn Wetterslev
Per Winkel
Pär I. Johansson
Jan Wernerman
Anne B. Guttormsen
Sari Karlsson
Anders Perner
The TRISS Trial Group
The Scandinavian Critical Care Trials Group
Publication date
01-11-2016
Publisher
Springer Berlin Heidelberg
Published in
Intensive Care Medicine / Issue 11/2016
Print ISSN: 0342-4642
Electronic ISSN: 1432-1238
DOI
https://doi.org/10.1007/s00134-016-4437-x

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