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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:protocol for a randomised controlled trial

Authors :
Holst, Lars B
Haase, Nicolai
Wetterslev, Jørn
Wernerman, Jan
Aneman, Anders
Guttormsen, Anne B
Johansson, Pär I
Karlsson, Sari
Klemenzson, Gudmundur
Winding, Robert
Nebrich, Lars
Albeck, Carsten
Vang, Marianne L
Bülow, Hans-Henrik
Elkjær, Jeanie M
Nielsen, Jane S
Kirkegaard, Peter
Nibro, Helle
Lindhardt, Anne
Strange, Ditte
Thormar, Katrin
Poulsen, Lone M
Berezowicz, Pawel
Bådstøløkken, Per M
Strand, Kristian
Cronhjort, Maria
Haunstrup, Elsebeth
Rian, Omar
Oldner, Anders
Bendtsen, Asger
Iversen, Susanne
Langva, Jørn-Åge
Johansen, Rasmus B
Nielsen, Niklas
Pettilä, Ville
Reinikainen, Matti
Keld, Dorte
Leivdal, Siv
Breider, Jan-Michael
Tjäder, Inga
Reiter, Nanna
Gøttrup, Ulf
White, Jonathan
Wiis, Jørgen
Andersen, Lasse Høgh
Steensen, Morten
Perner, Anders
Holst, Lars B
Haase, Nicolai
Wetterslev, Jørn
Wernerman, Jan
Aneman, Anders
Guttormsen, Anne B
Johansson, Pär I
Karlsson, Sari
Klemenzson, Gudmundur
Winding, Robert
Nebrich, Lars
Albeck, Carsten
Vang, Marianne L
Bülow, Hans-Henrik
Elkjær, Jeanie M
Nielsen, Jane S
Kirkegaard, Peter
Nibro, Helle
Lindhardt, Anne
Strange, Ditte
Thormar, Katrin
Poulsen, Lone M
Berezowicz, Pawel
Bådstøløkken, Per M
Strand, Kristian
Cronhjort, Maria
Haunstrup, Elsebeth
Rian, Omar
Oldner, Anders
Bendtsen, Asger
Iversen, Susanne
Langva, Jørn-Åge
Johansen, Rasmus B
Nielsen, Niklas
Pettilä, Ville
Reinikainen, Matti
Keld, Dorte
Leivdal, Siv
Breider, Jan-Michael
Tjäder, Inga
Reiter, Nanna
Gøttrup, Ulf
White, Jonathan
Wiis, Jørgen
Andersen, Lasse Høgh
Steensen, Morten
Perner, Anders
Source :
Holst , L B , Haase , N , Wetterslev , J , Wernerman , J , Aneman , A , Guttormsen , A B , Johansson , P I , Karlsson , S , Klemenzson , G , Winding , R , Nebrich , L , Albeck , C , Vang , M L , Bülow , H-H , Elkjær , J M , Nielsen , J S , Kirkegaard , P , Nibro , H , Lindhardt , A , Strange , D , Thormar , K , Poulsen , L M , Berezowicz , P , Bådstøløkken , P M , Strand , K , Cronhjort , M , Haunstrup , E , Rian , O , Oldner , A , Bendtsen , A , Iversen , S , Langva , J-Å , Johansen , R B , Nielsen , N , Pettilä , V , Reinikainen , M , Keld , D , Leivdal , S , Breider , J-M , Tjäder , I , Reiter , N , Gøttrup , U , White , J , Wiis , J , Andersen , L H , Steensen , M & Perner , A 2013 , ' 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 : protocol for a randomised controlled trial ' , Trials , vol. 14 , no. 1 , pp. 150 .
Publication Year :
2013

Abstract

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: 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

Details

Database :
OAIster
Journal :
Holst , L B , Haase , N , Wetterslev , J , Wernerman , J , Aneman , A , Guttormsen , A B , Johansson , P I , Karlsson , S , Klemenzson , G , Winding , R , Nebrich , L , Albeck , C , Vang , M L , Bülow , H-H , Elkjær , J M , Nielsen , J S , Kirkegaard , P , Nibro , H , Lindhardt , A , Strange , D , Thormar , K , Poulsen , L M , Berezowicz , P , Bådstøløkken , P M , Strand , K , Cronhjort , M , Haunstrup , E , Rian , O , Oldner , A , Bendtsen , A , Iversen , S , Langva , J-Å , Johansen , R B , Nielsen , N , Pettilä , V , Reinikainen , M , Keld , D , Leivdal , S , Breider , J-M , Tjäder , I , Reiter , N , Gøttrup , U , White , J , Wiis , J , Andersen , L H , Steensen , M & Perner , A 2013 , ' 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 : protocol for a randomised controlled trial ' , Trials , vol. 14 , no. 1 , pp. 150 .
Notes :
English
Publication Type :
Electronic Resource
Accession number :
edsoai.on1322638247
Document Type :
Electronic Resource