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
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...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Holst, Lars B [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2013 |
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| Schlagwörter: |
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| Anmerkung: |
© Holst et al.; licensee BioMed Central Ltd. 2013 |
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| Übergeordnetes Werk: |
Enthalten in: Trials - London : BioMed Central, 2000, 14(2013), 1 vom: 23. Mai |
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| Übergeordnetes Werk: |
volume:14 ; year:2013 ; number:1 ; day:23 ; month:05 |
| Links: |
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| DOI / URN: |
10.1186/1745-6215-14-150 |
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| Katalog-ID: |
SPR030062624 |
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| 245 | 1 | 0 | |a 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 |
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| 520 | |a 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. | ||
| 650 | 4 | |a Sepsis |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Septic shock |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Intensive care medicine |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Red blood cell transfusion |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Fluid therapy |7 (dpeaa)DE-He213 | |
| 700 | 1 | |a Haase, Nicolai |4 aut | |
| 700 | 1 | |a Wetterslev, Jørn |4 aut | |
| 700 | 1 | |a Wernerman, Jan |4 aut | |
| 700 | 1 | |a Åneman, Anders |4 aut | |
| 700 | 1 | |a Guttormsen, Anne B |4 aut | |
| 700 | 1 | |a Johansson, Pär I |4 aut | |
| 700 | 1 | |a Karlsson, Sari |4 aut | |
| 700 | 1 | |a Klemenzson, Gudmundur |4 aut | |
| 700 | 1 | |a Winding, Robert |4 aut | |
| 700 | 1 | |a Nebrich, Lars |4 aut | |
| 700 | 1 | |a Albeck, Carsten |4 aut | |
| 700 | 1 | |a Vang, Marianne L |4 aut | |
| 700 | 1 | |a Bülow, Hans-Henrik |4 aut | |
| 700 | 1 | |a Elkjær, Jeanie M |4 aut | |
| 700 | 1 | |a Nielsen, Jane S |4 aut | |
| 700 | 1 | |a Kirkegaard, Peter |4 aut | |
| 700 | 1 | |a Nibro, Helle |4 aut | |
| 700 | 1 | |a Lindhardt, Anne |4 aut | |
| 700 | 1 | |a Strange, Ditte |4 aut | |
| 700 | 1 | |a Thormar, Katrin |4 aut | |
| 700 | 1 | |a Poulsen, Lone M |4 aut | |
| 700 | 1 | |a Berezowicz, Pawel |4 aut | |
| 700 | 1 | |a Bådstøløkken, Per M |4 aut | |
| 700 | 1 | |a Strand, Kristian |4 aut | |
| 700 | 1 | |a Cronhjort, Maria |4 aut | |
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| 700 | 1 | |a Rian, Omar |4 aut | |
| 700 | 1 | |a Oldner, Anders |4 aut | |
| 700 | 1 | |a Bendtsen, Asger |4 aut | |
| 700 | 1 | |a Iversen, Susanne |4 aut | |
| 700 | 1 | |a Langva, Jørn-Åge |4 aut | |
| 700 | 1 | |a Johansen, Rasmus B |4 aut | |
| 700 | 1 | |a Nielsen, Niklas |4 aut | |
| 700 | 1 | |a Pettilä, Ville |4 aut | |
| 700 | 1 | |a Reinikainen, Matti |4 aut | |
| 700 | 1 | |a Keld, Dorte |4 aut | |
| 700 | 1 | |a Leivdal, Siv |4 aut | |
| 700 | 1 | |a Breider, Jan-Michael |4 aut | |
| 700 | 1 | |a Tjäder, Inga |4 aut | |
| 700 | 1 | |a Reiter, Nanna |4 aut | |
| 700 | 1 | |a Gøttrup, Ulf |4 aut | |
| 700 | 1 | |a White, Jonathan |4 aut | |
| 700 | 1 | |a Wiis, Jørgen |4 aut | |
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| 700 | 1 | |a Steensen, Morten |4 aut | |
| 700 | 1 | |a Perner, Anders |4 aut | |
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10.1186/1745-6215-14-150 doi (DE-627)SPR030062624 (SPR)1745-6215-14-150-e DE-627 ger DE-627 rakwb eng Holst, Lars B verfasserin aut 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 2013 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Holst et al.; licensee BioMed Central Ltd. 2013 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. Sepsis (dpeaa)DE-He213 Septic shock (dpeaa)DE-He213 Intensive care medicine (dpeaa)DE-He213 Red blood cell transfusion (dpeaa)DE-He213 Fluid therapy (dpeaa)DE-He213 Haase, Nicolai aut Wetterslev, Jørn aut Wernerman, Jan aut Åneman, Anders aut Guttormsen, Anne B aut Johansson, Pär I aut Karlsson, Sari aut Klemenzson, Gudmundur aut Winding, Robert aut Nebrich, Lars aut Albeck, Carsten aut Vang, Marianne L aut Bülow, Hans-Henrik aut Elkjær, Jeanie M aut Nielsen, Jane S aut Kirkegaard, Peter aut Nibro, Helle aut Lindhardt, Anne aut Strange, Ditte aut Thormar, Katrin aut Poulsen, Lone M aut Berezowicz, Pawel aut Bådstøløkken, Per M aut Strand, Kristian aut Cronhjort, Maria aut Haunstrup, Elsebeth aut Rian, Omar aut Oldner, Anders aut Bendtsen, Asger aut Iversen, Susanne aut Langva, Jørn-Åge aut Johansen, Rasmus B aut Nielsen, Niklas aut Pettilä, Ville aut Reinikainen, Matti aut Keld, Dorte aut Leivdal, Siv aut Breider, Jan-Michael aut Tjäder, Inga aut Reiter, Nanna aut Gøttrup, Ulf aut White, Jonathan aut Wiis, Jørgen aut Andersen, Lasse Høgh aut Steensen, Morten aut Perner, Anders aut Enthalten in Trials London : BioMed Central, 2000 14(2013), 1 vom: 23. Mai (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:14 year:2013 number:1 day:23 month:05 https://dx.doi.org/10.1186/1745-6215-14-150 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2013 1 23 05 |
| spelling |
10.1186/1745-6215-14-150 doi (DE-627)SPR030062624 (SPR)1745-6215-14-150-e DE-627 ger DE-627 rakwb eng Holst, Lars B verfasserin aut 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 2013 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Holst et al.; licensee BioMed Central Ltd. 2013 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. Sepsis (dpeaa)DE-He213 Septic shock (dpeaa)DE-He213 Intensive care medicine (dpeaa)DE-He213 Red blood cell transfusion (dpeaa)DE-He213 Fluid therapy (dpeaa)DE-He213 Haase, Nicolai aut Wetterslev, Jørn aut Wernerman, Jan aut Åneman, Anders aut Guttormsen, Anne B aut Johansson, Pär I aut Karlsson, Sari aut Klemenzson, Gudmundur aut Winding, Robert aut Nebrich, Lars aut Albeck, Carsten aut Vang, Marianne L aut Bülow, Hans-Henrik aut Elkjær, Jeanie M aut Nielsen, Jane S aut Kirkegaard, Peter aut Nibro, Helle aut Lindhardt, Anne aut Strange, Ditte aut Thormar, Katrin aut Poulsen, Lone M aut Berezowicz, Pawel aut Bådstøløkken, Per M aut Strand, Kristian aut Cronhjort, Maria aut Haunstrup, Elsebeth aut Rian, Omar aut Oldner, Anders aut Bendtsen, Asger aut Iversen, Susanne aut Langva, Jørn-Åge aut Johansen, Rasmus B aut Nielsen, Niklas aut Pettilä, Ville aut Reinikainen, Matti aut Keld, Dorte aut Leivdal, Siv aut Breider, Jan-Michael aut Tjäder, Inga aut Reiter, Nanna aut Gøttrup, Ulf aut White, Jonathan aut Wiis, Jørgen aut Andersen, Lasse Høgh aut Steensen, Morten aut Perner, Anders aut Enthalten in Trials London : BioMed Central, 2000 14(2013), 1 vom: 23. Mai (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:14 year:2013 number:1 day:23 month:05 https://dx.doi.org/10.1186/1745-6215-14-150 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2013 1 23 05 |
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10.1186/1745-6215-14-150 doi (DE-627)SPR030062624 (SPR)1745-6215-14-150-e DE-627 ger DE-627 rakwb eng Holst, Lars B verfasserin aut 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 2013 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Holst et al.; licensee BioMed Central Ltd. 2013 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. Sepsis (dpeaa)DE-He213 Septic shock (dpeaa)DE-He213 Intensive care medicine (dpeaa)DE-He213 Red blood cell transfusion (dpeaa)DE-He213 Fluid therapy (dpeaa)DE-He213 Haase, Nicolai aut Wetterslev, Jørn aut Wernerman, Jan aut Åneman, Anders aut Guttormsen, Anne B aut Johansson, Pär I aut Karlsson, Sari aut Klemenzson, Gudmundur aut Winding, Robert aut Nebrich, Lars aut Albeck, Carsten aut Vang, Marianne L aut Bülow, Hans-Henrik aut Elkjær, Jeanie M aut Nielsen, Jane S aut Kirkegaard, Peter aut Nibro, Helle aut Lindhardt, Anne aut Strange, Ditte aut Thormar, Katrin aut Poulsen, Lone M aut Berezowicz, Pawel aut Bådstøløkken, Per M aut Strand, Kristian aut Cronhjort, Maria aut Haunstrup, Elsebeth aut Rian, Omar aut Oldner, Anders aut Bendtsen, Asger aut Iversen, Susanne aut Langva, Jørn-Åge aut Johansen, Rasmus B aut Nielsen, Niklas aut Pettilä, Ville aut Reinikainen, Matti aut Keld, Dorte aut Leivdal, Siv aut Breider, Jan-Michael aut Tjäder, Inga aut Reiter, Nanna aut Gøttrup, Ulf aut White, Jonathan aut Wiis, Jørgen aut Andersen, Lasse Høgh aut Steensen, Morten aut Perner, Anders aut Enthalten in Trials London : BioMed Central, 2000 14(2013), 1 vom: 23. Mai (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:14 year:2013 number:1 day:23 month:05 https://dx.doi.org/10.1186/1745-6215-14-150 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2013 1 23 05 |
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10.1186/1745-6215-14-150 doi (DE-627)SPR030062624 (SPR)1745-6215-14-150-e DE-627 ger DE-627 rakwb eng Holst, Lars B verfasserin aut 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 2013 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Holst et al.; licensee BioMed Central Ltd. 2013 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. Sepsis (dpeaa)DE-He213 Septic shock (dpeaa)DE-He213 Intensive care medicine (dpeaa)DE-He213 Red blood cell transfusion (dpeaa)DE-He213 Fluid therapy (dpeaa)DE-He213 Haase, Nicolai aut Wetterslev, Jørn aut Wernerman, Jan aut Åneman, Anders aut Guttormsen, Anne B aut Johansson, Pär I aut Karlsson, Sari aut Klemenzson, Gudmundur aut Winding, Robert aut Nebrich, Lars aut Albeck, Carsten aut Vang, Marianne L aut Bülow, Hans-Henrik aut Elkjær, Jeanie M aut Nielsen, Jane S aut Kirkegaard, Peter aut Nibro, Helle aut Lindhardt, Anne aut Strange, Ditte aut Thormar, Katrin aut Poulsen, Lone M aut Berezowicz, Pawel aut Bådstøløkken, Per M aut Strand, Kristian aut Cronhjort, Maria aut Haunstrup, Elsebeth aut Rian, Omar aut Oldner, Anders aut Bendtsen, Asger aut Iversen, Susanne aut Langva, Jørn-Åge aut Johansen, Rasmus B aut Nielsen, Niklas aut Pettilä, Ville aut Reinikainen, Matti aut Keld, Dorte aut Leivdal, Siv aut Breider, Jan-Michael aut Tjäder, Inga aut Reiter, Nanna aut Gøttrup, Ulf aut White, Jonathan aut Wiis, Jørgen aut Andersen, Lasse Høgh aut Steensen, Morten aut Perner, Anders aut Enthalten in Trials London : BioMed Central, 2000 14(2013), 1 vom: 23. Mai (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:14 year:2013 number:1 day:23 month:05 https://dx.doi.org/10.1186/1745-6215-14-150 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2013 1 23 05 |
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10.1186/1745-6215-14-150 doi (DE-627)SPR030062624 (SPR)1745-6215-14-150-e DE-627 ger DE-627 rakwb eng Holst, Lars B verfasserin aut 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 2013 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Holst et al.; licensee BioMed Central Ltd. 2013 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. Sepsis (dpeaa)DE-He213 Septic shock (dpeaa)DE-He213 Intensive care medicine (dpeaa)DE-He213 Red blood cell transfusion (dpeaa)DE-He213 Fluid therapy (dpeaa)DE-He213 Haase, Nicolai aut Wetterslev, Jørn aut Wernerman, Jan aut Åneman, Anders aut Guttormsen, Anne B aut Johansson, Pär I aut Karlsson, Sari aut Klemenzson, Gudmundur aut Winding, Robert aut Nebrich, Lars aut Albeck, Carsten aut Vang, Marianne L aut Bülow, Hans-Henrik aut Elkjær, Jeanie M aut Nielsen, Jane S aut Kirkegaard, Peter aut Nibro, Helle aut Lindhardt, Anne aut Strange, Ditte aut Thormar, Katrin aut Poulsen, Lone M aut Berezowicz, Pawel aut Bådstøløkken, Per M aut Strand, Kristian aut Cronhjort, Maria aut Haunstrup, Elsebeth aut Rian, Omar aut Oldner, Anders aut Bendtsen, Asger aut Iversen, Susanne aut Langva, Jørn-Åge aut Johansen, Rasmus B aut Nielsen, Niklas aut Pettilä, Ville aut Reinikainen, Matti aut Keld, Dorte aut Leivdal, Siv aut Breider, Jan-Michael aut Tjäder, Inga aut Reiter, Nanna aut Gøttrup, Ulf aut White, Jonathan aut Wiis, Jørgen aut Andersen, Lasse Høgh aut Steensen, Morten aut Perner, Anders aut Enthalten in Trials London : BioMed Central, 2000 14(2013), 1 vom: 23. Mai (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:14 year:2013 number:1 day:23 month:05 https://dx.doi.org/10.1186/1745-6215-14-150 kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2013 1 23 05 |
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Holst, Lars B @@aut@@ Haase, Nicolai @@aut@@ Wetterslev, Jørn @@aut@@ Wernerman, Jan @@aut@@ Åneman, Anders @@aut@@ Guttormsen, Anne B @@aut@@ Johansson, Pär I @@aut@@ Karlsson, Sari @@aut@@ Klemenzson, Gudmundur @@aut@@ Winding, Robert @@aut@@ Nebrich, Lars @@aut@@ Albeck, Carsten @@aut@@ Vang, Marianne L @@aut@@ Bülow, Hans-Henrik @@aut@@ Elkjær, Jeanie M @@aut@@ Nielsen, Jane S @@aut@@ Kirkegaard, Peter @@aut@@ Nibro, Helle @@aut@@ Lindhardt, Anne @@aut@@ Strange, Ditte @@aut@@ Thormar, Katrin @@aut@@ Poulsen, Lone M @@aut@@ Berezowicz, Pawel @@aut@@ Bådstøløkken, Per M @@aut@@ Strand, Kristian @@aut@@ Cronhjort, Maria @@aut@@ Haunstrup, Elsebeth @@aut@@ Rian, Omar @@aut@@ Oldner, Anders @@aut@@ Bendtsen, Asger @@aut@@ Iversen, Susanne @@aut@@ Langva, Jørn-Åge @@aut@@ Johansen, Rasmus B @@aut@@ Nielsen, Niklas @@aut@@ Pettilä, Ville @@aut@@ Reinikainen, Matti @@aut@@ Keld, Dorte @@aut@@ Leivdal, Siv @@aut@@ Breider, Jan-Michael @@aut@@ Tjäder, Inga @@aut@@ Reiter, Nanna @@aut@@ Gøttrup, Ulf @@aut@@ White, Jonathan @@aut@@ Wiis, Jørgen @@aut@@ Andersen, Lasse Høgh @@aut@@ Steensen, Morten @@aut@@ Perner, Anders @@aut@@ |
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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 Sepsis (dpeaa)DE-He213 Septic shock (dpeaa)DE-He213 Intensive care medicine (dpeaa)DE-He213 Red blood cell transfusion (dpeaa)DE-He213 Fluid therapy (dpeaa)DE-He213 |
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Holst, Lars B Haase, Nicolai Wetterslev, Jørn Wernerman, Jan Åneman, 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 |
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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 |
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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 |
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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. © Holst et al.; licensee BioMed Central Ltd. 2013 |
| abstractGer |
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. © Holst et al.; licensee BioMed Central Ltd. 2013 |
| abstract_unstemmed |
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. © Holst et al.; licensee BioMed Central Ltd. 2013 |
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<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">SPR030062624</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230519173436.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">201007s2013 xx |||||o 00| ||eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1186/1745-6215-14-150</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)SPR030062624</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(SPR)1745-6215-14-150-e</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Holst, Lars B</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">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</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2013</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">© Holst et al.; licensee BioMed Central Ltd. 2013</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">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. 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