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

Lars B Holst; Nicolai Haase; Jørn Wetterslev; Jan Wernerman; Anders Aneman; Anne B Guttormsen; Pär I Johansson; Sari Karlsson; Gudmundur Klemenzson; Robert Winding; Lars Nebrich; Carsten Albeck; Marianne L Vang; Hans-Henrik Bülow; Jeanie M Elkjær; Jane S Nielsen; Peter Kirkegaard; Helle Nibro; Anne Lindhardt; Ditte Strange; Katrin Thormar; Lone M Poulsen; Pawel Berezowicz; Per M Bådstøløkken; Kristian Strand; Maria Cronhjort; Elsebeth Haunstrup; Omar Rian; Anders Oldner; Asger Bendtsen; Susanne Iversen; Jørn-Åge Langva; Rasmus B Johansen; Niklas Nielsen; Ville Pettilä; Matti Reinikainen; Dorte Keld; Siv Leivdal; Jan-Michael Breider; Inga Tjäder; Nanna Reiter; Ulf Gøttrup; Jonathan White; Jørgen Wiis; Lasse Høgh Andersen; Morten Steensen; Anders Perner

doi:10.1186/1745-6215-14-150

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

Lars B Holst, Nicolai Haase, Jørn Wetterslev, Jan Wernerman, Anders Aneman, Anne B Guttormsen, Pär I Johansson, Sari Karlsson, Gudmundur Klemenzson, Robert Winding, Lars Nebrich, Carsten Albeck, Marianne L Vang, Hans-Henrik Bülow, Jeanie M Elkjær, Jane S Nielsen, Peter Kirkegaard, Helle Nibro, Anne Lindhardt, Ditte StrangeKatrin Thormar, Lone M Poulsen, Pawel Berezowicz, Per M Bådstøløkken, Kristian Strand, Maria Cronhjort, Elsebeth Haunstrup, Omar Rian, Anders Oldner, Asger Bendtsen, Susanne Iversen, Jørn-Åge Langva, Rasmus B Johansen, Niklas Nielsen, Ville Pettilä, Matti Reinikainen, Dorte Keld, Siv Leivdal, Jan-Michael Breider, Inga Tjäder, Nanna Reiter, Ulf Gøttrup, Jonathan White, Jørgen Wiis, Lasse Høgh Andersen, Morten Steensen, Anders Perner

35 Citationer (Scopus)

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/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.

Originalsprog	Engelsk
Tidsskrift	Trials
Vol/bind	14
Udgave nummer	1
Sider (fra-til)	150
ISSN	1745-6215
DOI	https://doi.org/10.1186/1745-6215-14-150
Status	Udgivet - 23 maj 2013

Adgang til dokumentet

10.1186/1745-6215-14-150

Fingeraftryk

Dyk ned i forskningsemnerne om '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'. Sammen danner de et unikt fingeraftryk.

Citationsformater

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., ... 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, 14(1), 150. https://doi.org/10.1186/1745-6215-14-150

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. / Holst, Lars B; Haase, Nicolai; Wetterslev, Jørn et al.

I: Trials, Bind 14, Nr. 1, 23.05.2013, s. 150.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

Holst, LB, Haase, N, Wetterslev, J, Wernerman, J, Aneman, A, Guttormsen, AB, Johansson, PI, Karlsson, S, Klemenzson, G, Winding, R, Nebrich, L, Albeck, C, Vang, ML, Bülow, H-H, Elkjær, JM, Nielsen, JS, Kirkegaard, P, Nibro, H, Lindhardt, A, Strange, D, Thormar, K, Poulsen, LM, Berezowicz, P, Bådstøløkken, PM, Strand, K, Cronhjort, M, Haunstrup, E, Rian, O, Oldner, A, Bendtsen, A, Iversen, S, Langva, J-Å, Johansen, RB, Nielsen, N, Pettilä, V, Reinikainen, M, Keld, D, Leivdal, S, Breider, J-M, Tjäder, I, Reiter, N, Gøttrup, U, White, J, Wiis, J, Andersen, LH, 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, bind 14, nr. 1, s. 150. https://doi.org/10.1186/1745-6215-14-150

@article{30ce5ee6bc60463ba6f3803cb0143378,

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/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.",

author = "Holst, {Lars B} and Nicolai Haase and J{\o}rn Wetterslev and Jan Wernerman and Anders Aneman and Guttormsen, {Anne B} and Johansson, {P{\"a}r I} and Sari Karlsson and Gudmundur Klemenzson and Robert Winding and Lars Nebrich and Carsten Albeck and Vang, {Marianne L} and Hans-Henrik B{\"u}low and Elkj{\ae}r, {Jeanie M} and Nielsen, {Jane S} and Peter Kirkegaard and Helle Nibro and Anne Lindhardt and Ditte Strange and Katrin Thormar and Poulsen, {Lone M} and Pawel Berezowicz and B{\aa}dst{\o}l{\o}kken, {Per M} and Kristian Strand and Maria Cronhjort and Elsebeth Haunstrup and Omar Rian and Anders Oldner and Asger Bendtsen and Susanne Iversen and J{\o}rn-{\AA}ge Langva and Johansen, {Rasmus B} and Niklas Nielsen and Ville Pettil{\"a} and Matti Reinikainen and Dorte Keld and Siv Leivdal and Jan-Michael Breider and Inga Tj{\"a}der and Nanna Reiter and Ulf G{\o}ttrup and Jonathan White and J{\o}rgen Wiis and Andersen, {Lasse H{\o}gh} and Morten Steensen and Anders Perner",

year = "2013",

month = may,

day = "23",

doi = "10.1186/1745-6215-14-150",

language = "English",

volume = "14",

pages = "150",

journal = "Trials",

issn = "1745-6215",

publisher = "BioMed Central Ltd.",

number = "1",

}

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 - Aneman, 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.

U2 - 10.1186/1745-6215-14-150

DO - 10.1186/1745-6215-14-150

M3 - Journal article

C2 - 23702006

SN - 1745-6215

VL - 14

SP - 150

JO - Trials

JF - Trials

IS - 1

ER -