Long-term outcomes in patients with septic shock transfused at a lower versus a higher haemoglobin threshold: the TRISS randomised, multicentre clinical trial.
OBJECTIVE
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.
Department of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Sofie L
SL
Rygård
Department of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Lars B
LB
Holst
Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Jørn
J
Wetterslev
Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Per
P
Winkel
Section for Transfusion Medicine, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Pär I
PI
Johansson
Karolinska University Hospital, Huddinge, Sweden.
Jan
J
Wernerman
Haukeland University Hospital and University of Bergen, Bergen, Norway.
Anne B
AB
Guttormsen
Tampere University Hospital, Tampere, Finland.
Sari
S
Karlsson
Department of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark. anders.perner@regionh.dk.|Centre for Research in Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. anders.perner@regionh.dk.
Anders
A
Perner
D000368:Aged; D000740:Anemia / Q000150:complications / Q000401:mortality* / Q000628:therapy; D017707:Erythrocyte Transfusion / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006454:Hemoglobins / Q000032:analysis*; D006801:Humans; D007362:Intensive Care Units / Q000706:statistics & numerical data; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012306:Risk; D012772:Shock, Septic / Q000097:blood / Q000150:complications / Q000401:mortality* / Q000628:therapy; D013997:Time Factors
D006454:Hemoglobins
Blood transfusion; Critical care; Hemoglobin; Intensive care unit; Red blood cell transfusion; Septic shock
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