title: 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.
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 ≤0.001 is present at this point.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Denmark. Lars.Broksoe.Holst@regionh.dk
authors.forename: Lars B
authors.initials: LB
authors.lastname: Holst
authors.forename: Nicolai
authors.initials: N
authors.lastname: Haase
authors.forename: Jørn
authors.initials: J
authors.lastname: Wetterslev
authors.forename: Jan
authors.initials: J
authors.lastname: Wernerman
authors.forename: Anders
authors.initials: A
authors.lastname: Aneman
authors.forename: Anne B
authors.initials: AB
authors.lastname: Guttormsen
authors.forename: Pär I
authors.initials: PI
authors.lastname: Johansson
authors.forename: Sari
authors.initials: S
authors.lastname: Karlsson
authors.forename: Gudmundur
authors.initials: G
authors.lastname: Klemenzson
authors.forename: Robert
authors.initials: R
authors.lastname: Winding
authors.forename: Lars
authors.initials: L
authors.lastname: Nebrich
authors.forename: Carsten
authors.initials: C
authors.lastname: Albeck
authors.forename: Marianne L
authors.initials: ML
authors.lastname: Vang
authors.forename: Hans-Henrik
authors.initials: HH
authors.lastname: Bülow
authors.forename: Jeanie M
authors.initials: JM
authors.lastname: Elkjær
authors.forename: Jane S
authors.initials: JS
authors.lastname: Nielsen
authors.forename: Peter
authors.initials: P
authors.lastname: Kirkegaard
authors.forename: Helle
authors.initials: H
authors.lastname: Nibro
authors.forename: Anne
authors.initials: A
authors.lastname: Lindhardt
authors.forename: Ditte
authors.initials: D
authors.lastname: Strange
authors.forename: Katrin
authors.initials: K
authors.lastname: Thormar
authors.forename: Lone M
authors.initials: LM
authors.lastname: Poulsen
authors.forename: Pawel
authors.initials: P
authors.lastname: Berezowicz
authors.forename: Per M
authors.initials: PM
authors.lastname: Bådstøløkken
authors.forename: Kristian
authors.initials: K
authors.lastname: Strand
authors.forename: Maria
authors.initials: M
authors.lastname: Cronhjort
authors.forename: Elsebeth
authors.initials: E
authors.lastname: Haunstrup
authors.forename: Omar
authors.initials: O
authors.lastname: Rian
authors.forename: Anders
authors.initials: A
authors.lastname: Oldner
authors.forename: Asger
authors.initials: A
authors.lastname: Bendtsen
authors.forename: Susanne
authors.initials: S
authors.lastname: Iversen
authors.forename: Jørn-Åge
authors.initials: JÅ
authors.lastname: Langva
authors.forename: Rasmus B
authors.initials: RB
authors.lastname: Johansen
authors.forename: Niklas
authors.initials: N
authors.lastname: Nielsen
authors.forename: Ville
authors.initials: V
authors.lastname: Pettilä
authors.forename: Matti
authors.initials: M
authors.lastname: Reinikainen
authors.forename: Dorte
authors.initials: D
authors.lastname: Keld
authors.forename: Siv
authors.initials: S
authors.lastname: Leivdal
authors.forename: Jan-Michael
authors.initials: JM
authors.lastname: Breider
authors.forename: Inga
authors.initials: I
authors.lastname: Tjäder
authors.forename: Nanna
authors.initials: N
authors.lastname: Reiter
authors.forename: Ulf
authors.initials: U
authors.lastname: Gøttrup
authors.forename: Jonathan
authors.initials: J
authors.lastname: White
authors.forename: Jørgen
authors.initials: J
authors.lastname: Wiis
authors.forename: Lasse Høgh
authors.initials: LH
authors.lastname: Andersen
authors.forename: Morten
authors.initials: M
authors.lastname: Steensen
authors.forename: Anders
authors.initials: A
authors.lastname: Perner
mesh_terms: D015415:Biomarkers / Q000097:blood; D002985:Clinical Protocols; D026661:Clinical Trials Data Monitoring Committees; D017707:Erythrocyte Transfusion / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D005440:Fluid Therapy; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007055:Iceland; D007362:Intensive Care Units; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D012537:Scandinavian and Nordic Countries; D012772:Shock, Septic / Q000097:blood / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D006454:Hemoglobins