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

Autor: Lars Nebrich, Jan-Michael Breider, Siv Leivdal, Nanna Reiter, Inga Tjäder, Anders Oldner, Jonathan White, Lars B. Holst, Gudmundur Klemenzson, Hans-Henrik Bülow, Jørgen Wiis, Anders Perner, Rasmus Broby Johansen, Jeanie M. Elkjær, Jørn Wetterslev, Omar Rian, Lasse H. Andersen, Susanne Iversen, Pär I. Johansson, Lone Musaeus Poulsen, Elsebeth Haunstrup, Helle Lykkeskov Nibro, Robert Winding, Per Martin Bådstøløkken, Kristian Strand, Sari Karlsson, Nicolai Haase, Ville Pettilä, Ulf Gøttrup, Carsten Albeck, Ditte Strange, Anders Aneman, Dorte Keld, Peter Roy Casparij Kirkegaard, Jørn-Åge Langva, Jan Wernerman, Niklas Nielsen, Pawel Berezowicz, Katrin Thormar, Asger Bendtsen, Matti Reinikainen, Anne Berit Guttormsen, Marianne L. Vang, Anne Lindhardt, Maria Cronhjort, Morten Steensen, Jane S. Nielsen
Jazyk: angličtina
Rok vydání: 2013
Předmět:
Time Factors
Iceland
Medicine (miscellaneous)
Red blood cell transfusion
law.invention
Study Protocol
Hemoglobins
0302 clinical medicine
Fluid therapy
Clinical Protocols
law
Risk Factors
Septic shock
Pharmacology (medical)
030212 general & internal medicine
hemic and immune systems
Intensive care unit
Shock
Septic
3. Good health
Intensive Care Units
Treatment Outcome
Research Design
Shock (circulatory)
Biological Markers
Scandinavia
medicine.symptom
Clinical Trials Data Monitoring Committees
Erythrocyte Transfusion
circulatory and respiratory physiology
medicine.medical_specialty
Lung injury
Scandinavian and Nordic Countries
Risk Assessment
Sepsis
03 medical and health sciences
Intensive care
Multicenter trial
medicine
Humans
Intensive care medicine
business.industry
030208 emergency & critical care medicine
medicine.disease
Clinical trial
Emergency medicine
business
Biomarkers
Zdroj: Trials
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 G, Thormar, K, Poulsen, L M, Berezowicz, P, Bådstøløkken, P M, Strand, K, Cronhjort, M, Haunstrup, E, Rian, O, Oldner, A, Bendtsen, A O, 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 O, 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, pp. 150 . https://doi.org/10.1186/1745-6215-14-150
ISSN: 1745-6215
Popis: 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. 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. 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. ClinicalTrials.gov: NCT01485315 . Registration date 30 November 2011. First patient was randomised 3 December 2011.
Databáze: OpenAIRE
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