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

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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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Author information

Authors and Affiliations

  1. Department of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark

    Sofie L. Rygård, Lars B. Holst & Anders Perner

  2. Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark

    Jørn Wetterslev & Per Winkel

  3. Section for Transfusion Medicine, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark

    Pär I. Johansson

  4. Karolinska University Hospital, Huddinge, Sweden

    Jan Wernerman

  5. Haukeland University Hospital and University of Bergen, Bergen, Norway

    Anne B. Guttormsen

  6. Tampere University Hospital, Tampere, Finland

    Sari Karlsson

  7. Centre for Research in Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark

    Anders Perner

Authors
  1. Sofie L. Rygård
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  2. Lars B. Holst
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  4. Per Winkel
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  5. Pär I. Johansson
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  6. Jan Wernerman
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  7. Anne B. Guttormsen
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  8. Sari Karlsson
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  9. Anders Perner
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Consortia

The TRISS Trial Group

The Scandinavian Critical Care Trials Group

Corresponding author

Correspondence to Anders Perner.

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Funding

The trial was funded by the Danish Strategic Research Council and supported by Copenhagen University Hospital, Rigshospitalet, the Scandinavian Society of Anaesthesiology and Intensive Care Medicine (the ACTA Foundation) and Ehrenreich’s Foundation. The funders had no role in the design of the study, collection and analyses of data or the writing of the report. The TRISS trial was endorsed by the European Clinical Research Infrastructures Network (ECRIN).

Conflicts of interest

The Department of Intensive Care, Rigshospitalet receives support for research from CSL Behring, Fresenius Kabi and Ferring Pharmaceuticals. No other potential conflict of interest relevant to this article was reported.

Additional information

Members of the Transfusion Requirements in Septic Shock (TRISS) Trial Group are listed in the Electronic Supplementary Material 1.

Take-home message: In patients with septic shock, we may reject a more than 3 % increased long-term hazard of death with transfusion at a lower versus a higher haemoglobin threshold.

Electronic supplementary material

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Supplementary material 1 (PDF 729 kb)

Supplementary material 2 (PDF 1782 kb)

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Rygård, S.L., Holst, L.B., Wetterslev, J. et al. Long-term outcomes in patients with septic shock transfused at a lower versus a higher haemoglobin threshold: the TRISS randomised, multicentre clinical trial. Intensive Care Med 42, 1685–1694 (2016). https://doi.org/10.1007/s00134-016-4437-x

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  • DOI: https://doi.org/10.1007/s00134-016-4437-x

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