TY - JOUR
T1 - Transfusion requirements in septic shock (TRISS) trial - comparing the effects and safety of liberal versus restrictive red blood cell transfusion in septic shock patients in the ICU
T2 - Protocol for a randomised controlled trial
AU - Holst, Lars B.
AU - Haase, Nicolai
AU - Wetterslev, Jørn
AU - Wernerman, Jan
AU - Åneman, Anders
AU - Guttormsen, Anne B.
AU - Johansson, Pär I.
AU - Karlsson, Sari
AU - Klemenzson, Gudmundur
AU - Winding, Robert
AU - Nebrich, Lars
AU - Albeck, Carsten
AU - Vang, Marianne L.
AU - Bülow, Hans Henrik
AU - Elkjær, Jeanie M.
AU - Nielsen, Jane S.
AU - Kirkegaard, Peter
AU - Nibro, Helle
AU - Lindhardt, Anne
AU - Strange, Ditte
AU - Thormar, Katrin
AU - Poulsen, Lone M.
AU - Berezowicz, Pawel
AU - Bådstøløkken, Per M.
AU - Strand, Kristian
AU - Cronhjort, Maria
AU - Haunstrup, Elsebeth
AU - Rian, Omar
AU - Oldner, Anders
AU - Bendtsen, Asger
AU - Iversen, Susanne
AU - Langva, Jørn Åge
AU - Johansen, Rasmus B.
AU - Nielsen, Niklas
AU - Pettilä, Ville
AU - Reinikainen, Matti
AU - Keld, Dorte
AU - Leivdal, Siv
AU - Breider, Jan Michael
AU - Tjäder, Inga
AU - Reiter, Nanna
AU - Gøttrup, Ulf
AU - White, Jonathan
AU - Wiis, Jørgen
AU - Andersen, Lasse Høgh
AU - Steensen, Morten
AU - Perner, Anders
PY - 2013/5/23
Y1 - 2013/5/23
N2 - Background: Transfusion of red blood cells (RBC) is recommended in septic shock and the majority of these patients receive RBC transfusion in the intensive care unit (ICU). However, benefit and harm of RBCs have not been established in this group of high-risk patients.Methods/Design: The Transfusion Requirements in Septic Shock (TRISS) trial is a multicenter trial with assessor-blinded outcome assessment, randomising 1,000 patients with septic shock in 30 Scandinavian ICUs to receive transfusion with pre-storage leuko-depleted RBC suspended in saline-adenine-glucose and mannitol (SAGM) at haemoglobin level (Hb) of 7 g/dl or 9 g/dl, stratified by the presence of haematological malignancy and centre. The primary outcome measure is 90-day mortality. Secondary outcome measures are organ failure, ischaemic events, severe adverse reactions (SARs: anaphylactic reaction, acute haemolytic reaction and transfusion-related circulatory overload, and acute lung injury) and mortality at 28 days, 6 months and 1 year.The sample size will enable us to detect a 9% absolute difference in 90-day mortality assuming a 45% event rate with a type 1 error rate of 5% and power of 80%. An interim analysis will be performed after 500 patients, and the Data Monitoring and Safety Committee will recommend the trial be stopped if a group difference in 90-day mortality with P ≤0.001 is present at this point.Discussion: The TRISS trial may bridge the gap between clinical practice and the lack of efficacy and safety data on RBC transfusion in septic shock patients. The effect of restrictive versus liberal RBC transfusion strategy on mortality, organ failure, ischaemic events and SARs will be evaluated.Trial registration: ClinicalTrials.gov: NCT01485315. Registration date 30 November 2011. First patient was randomised 3 December 2011.
AB - Background: Transfusion of red blood cells (RBC) is recommended in septic shock and the majority of these patients receive RBC transfusion in the intensive care unit (ICU). However, benefit and harm of RBCs have not been established in this group of high-risk patients.Methods/Design: The Transfusion Requirements in Septic Shock (TRISS) trial is a multicenter trial with assessor-blinded outcome assessment, randomising 1,000 patients with septic shock in 30 Scandinavian ICUs to receive transfusion with pre-storage leuko-depleted RBC suspended in saline-adenine-glucose and mannitol (SAGM) at haemoglobin level (Hb) of 7 g/dl or 9 g/dl, stratified by the presence of haematological malignancy and centre. The primary outcome measure is 90-day mortality. Secondary outcome measures are organ failure, ischaemic events, severe adverse reactions (SARs: anaphylactic reaction, acute haemolytic reaction and transfusion-related circulatory overload, and acute lung injury) and mortality at 28 days, 6 months and 1 year.The sample size will enable us to detect a 9% absolute difference in 90-day mortality assuming a 45% event rate with a type 1 error rate of 5% and power of 80%. An interim analysis will be performed after 500 patients, and the Data Monitoring and Safety Committee will recommend the trial be stopped if a group difference in 90-day mortality with P ≤0.001 is present at this point.Discussion: The TRISS trial may bridge the gap between clinical practice and the lack of efficacy and safety data on RBC transfusion in septic shock patients. The effect of restrictive versus liberal RBC transfusion strategy on mortality, organ failure, ischaemic events and SARs will be evaluated.Trial registration: ClinicalTrials.gov: NCT01485315. Registration date 30 November 2011. First patient was randomised 3 December 2011.
KW - Fluid therapy
KW - Intensive care medicine
KW - Red blood cell transfusion
KW - Sepsis
KW - Septic shock
UR - http://www.scopus.com/inward/record.url?scp=84878004858&partnerID=8YFLogxK
U2 - 10.1186/1745-6215-14-150
DO - 10.1186/1745-6215-14-150
M3 - Protocol
C2 - 23702006
AN - SCOPUS:84878004858
SN - 1745-6215
VL - 14
JO - Trials
JF - Trials
IS - 1
M1 - 150
ER -