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

Volumn 14, Issue 1, 2013, Pages

  Holst, Lars B ^a   Haase, Nicolai ^a   Wetterslev, Jørn ^a   Wernerman, Jan ^b   Åneman, Anders ^c   Guttormsen, Anne B ^d   Johansson, Pär I ^a   Karlsson, Sari ^e   Klemenzson, Gudmundur ^f   Winding, Robert ^g   Nebrich, Lars ^h   Albeck, Carsten ^h   Vang, Marianne L ⁱ   Bülow, Hans Henrik ^j   Elkjær, Jeanie M ^j   Nielsen, Jane S ^k   Kirkegaard, Peter ^l   Nibro, Helle ^m   Lindhardt, Anne ⁿ   Strange, Ditte ⁿ   Thormar, Katrin ⁿ   Poulsen, Lone M ^o   Berezowicz, Pawel ^p   Bådstøløkken, Per M ^q   Strand, Kristian ^r   Cronhjort, Maria ^s   Haunstrup, Elsebeth ^t   Rian, Omar ^t   Oldner, Anders ^b   Bendtsen, Asger ^u   Iversen, Susanne ^o   Langva, Jørn Åge ^v   Johansen, Rasmus B ^v   Nielsen, Niklas ^w   Pettilä, Ville ^x   Reinikainen, Matti ^y   Keld, Dorte ^m   Leivdal, Siv ^z   Breider, Jan Michael ^f   Tjäder, Inga ^b   Reiter, Nanna ^a   Gøttrup, Ulf ^a   White, Jonathan ^a   Wiis, Jørgen ^a   Andersen, Lasse Høgh ^a   Steensen, Morten ^a   Perner, Anders ^a   more..

^a Rigshospitalet   (Denmark)

^b KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^c LIVERPOOL HOSPITAL   (Australia)

^d HAUKELAND UNIVERSITY HOSPITAL   (Norway)

^e TAMPERE UNIVERSITY HOSPITAL   (Finland)

^f Landspitalet ^*  (Sweden)

^g HERNING HOSPITAL   (Denmark)

^h HVIDOVRE HOSPITAL   (Denmark)

ⁱ RANDERS REGIONAL HOSPITAL   (Denmark)

^j HOLBÆK HOSPITAL   (Denmark)

^k KOLDING HOSPITAL   (Denmark)

^l NAESTVED HOSPITAL   (Denmark)

^m AARHUS UNIVERSITY HOSPITAL   (Denmark)

ⁿ BISPEBJERG HOSPITAL   (Denmark)

^o SLAGELSE HOSPITAL   (Denmark)

^p LILLEBAELT HOSPITAL   (Denmark)

^q GENTOFTE UNIVERSITY HOSPITAL   (Denmark)

^r Stavanger Hospital   (Norway)

^s STOCKHOLM SÖDER HOSPITAL   (Sweden)

^t HORSENS REGIONAL HOSPITAL   (Denmark)

^u GLOSTRUP UNIVERSITY HOSPITAL   (Denmark)

^v A lesund Hospital   (Norway)

^w HELSINGBORG HOSPITAL   (Sweden)

^x HELSINKI UNIVERSITY CENTRAL HOSPITAL   (Finland)

^y NORTH KARELIA CENTRAL HOSPITAL   (Finland)

^z Anæstesiologisk Center   (Denmark)

more..

Author keywords

Fluid therapy; Intensive care medicine; Red blood cell transfusion; Sepsis; Septic shock

Indexed keywords

ADENINE; GLUCOSE; HEMOGLOBIN; MANNITOL; SODIUM CHLORIDE;

ACUTE LUNG INJURY; ADULT; ANAPHYLAXIS; ARTICLE; CONTROLLED STUDY; ERYTHROCYTE; ERYTHROCYTE TRANSFUSION; HEMATOLOGIC MALIGNANCY; HIGH RISK PATIENT; HUMAN; INTENSIVE CARE UNIT; ISCHEMIA; LIBERAL RED BLOOD CELL TRANSFUSION; MAJOR CLINICAL STUDY; MORTALITY; MULTICENTER STUDY; OUTCOME ASSESSMENT; RANDOMIZED CONTROLLED TRIAL; RESTRICTIVE RED BLOOD CELL TRANSFUSION; SAMPLE SIZE; SEPTIC SHOCK;

BIOLOGICAL MARKERS; CLINICAL PROTOCOLS; CLINICAL TRIALS DATA MONITORING COMMITTEES; ERYTHROCYTE TRANSFUSION; FLUID THERAPY; HEMOGLOBINS; HUMANS; ICELAND; INTENSIVE CARE UNITS; RESEARCH DESIGN; RISK ASSESSMENT; RISK FACTORS; SCANDINAVIA; SHOCK, SEPTIC; TIME FACTORS; TREATMENT OUTCOME;

EID: 84878004858     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-14-150     Document Type: Article

References (44)

1. Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb S, Beale RJ, Vincent J-L, Moreno R. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock, 2012. Intensive Care Med 2013, 39:165-228. 10.1007/s00134-012-2769-8, 23361625.
2. Vincent JL, Baron JF, Reinhart K, Gattinoni L, Thijs L, Webb A. Anemia and blood transfusion in critically ill patients. JAMA 2002, 288:1499-1507. 10.1001/jama.288.12.1499, 12243637.
3. Corwin HL, Gettinger A, Pearl RG, Fink MP, Levy MM, Abraham E. The CRIT Study: Anemia and blood transfusion in the critically ill-current clinical practice in the United States. Crit Care Med 2004, 32:39-52. 10.1097/01.CCM.0000104112.34142.79, 14707558.
4. Finfer S, Liu B, Taylor C, Bellomo R, Billot L, Cook D. Resuscitation fluid use in critically ill adults: an international cross-sectional study in 391 intensive care units. Crit Care 2010, 14:R185. 10.1186/cc9293, 3219291, 20950434.
5. Perner A, Smith SH, Carlsen S, Holst LB. Red blood cell transfusion during septic shock in the ICU. Acta Anaesthesiol Scand 2012, 56:718-723. 10.1111/j.1399-6576.2012.02666.x, 22385470.
6. Trzeciak S, Dellinger RP, Parrillo JE, Guglielmi M, Bajaj J, Abate NL. Early microcirculatory perfusion derangements in patients with severe sepsis and septic shock: relationship to hemodynamics, oxygen transport, and survival. Ann Emerg Med 2007, 49:88-98. 10.1016/j.annemergmed.2006.08.021, 17095120.
7. Napolitano LM, Corwin HL. Efficacy of red blood cell transfusion in the critically ill. Crit Care Clin 2004, 20:255-268. 10.1016/j.ccc.2003.12.002, 15135464.
8. Goldman D, Bateman RM, Ellis CG. Effect of decreased O2 supply on skeletal muscle oxygenation and O2 consumption during sepsis: role of heterogeneous capillary spacing and blood flow. Am J Physiol Heart Circ Physiol 2006, 290:H2277-H2285. 10.1152/ajpheart.00547.2005, 16399873.
9. Triulzi DJ, Yazer MH. Clinical studies of the effect of blood storage on patient outcomes. Trans Aphe Sci 2010, 43:95-106.
10. Frenzel T, Westphal-Varghese B, Westphal M. Role of storage time of red blood cells on microcirculation and tissue oxygenation in critically ill patients. Curr Opin Anaes 2009, 22:275-280.
11. Fink MP. Bench-to-bedside review: Cytopathic hypoxia. Crit Care 2002, 6:491-499. 10.1186/cc1824, 153437, 12493070.
12. Singer M. Mitochondrial function in sepsis: acute phase versus multiple organ failure. Crit Care Med 2007, 35:S441-S448. 10.1097/01.CCM.0000278049.48333.78, 17713391.
13. Sjovall F, Morota S, Hansson MJ, Friberg H, Gnaiger E, Elmer E. Temporal increase of platelet mitochondrial respiration is negatively associated with clinical outcome in patients with sepsis. Crit Care 2010, 14:R214. 10.1186/cc9337, 3219983, 21106065.
14. Benson AB, Moss M, Silliman CC. Transfusion-related acute lung injury (TRALI): a clinical review with emphasis on the critically ill. Br J Haematol 2009, 147:431-443. 10.1111/j.1365-2141.2009.07840.x, 19663827.
15. Pettila V, Westbrook AJ, Nichol AD, Bailey MJ, Wood EM, Syres G. Age of red blood cells and mortality in the critically ill. Crit Care 2011, 15:R116. 10.1186/cc10142, 3219399, 21496231.
16. Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med 2001, 345:1368-1377. 10.1056/NEJMoa010307, 11794169.
17. Hebert PC, Wells G, Blajchman MA, Marshall J, Martin C, Pagliarello G, Tweeddale M, Schweitzer I, Yetisir E. A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. Transfusion Requirements in Critical Care Investigators, Canadian Critical Care Trials Group. N Engl J Med 1999, 340:409-417. 10.1056/NEJM199902113400601, 9971864.
18. Carson JL, Carless PA, Hebert PC. Transfusion thresholds and other strategies for guiding allogeneic red blood cell transfusion. Coch Database Syst Rev 2012, 4. CD002042.
19. Perner A, Haase N, Guttormsen AB, Tenhunen J, Klemenzson G, Aneman A, Madsen KR, Møller MH, Elkjær JM, Poulsen LM, Bendtsen A, Winding R, Steensen M, Berezowicz P, Søe-Jensen P, Bestle M, Strand K, Wiis J, White JO, Thornberg KJ, Quist L, Nielsen J, Andersen LH, Holst LB, Thormar K, Kjældgaard AL, Fabritius ML, Mondrup F, Pott FC, Møller TP, et al. Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis. N Engl J Med 2012, 367:124-134. 10.1056/NEJMoa1204242, 22738085.
20. Rosland RG, Hagen MU, Haase N, Perner A. Clinical characteristics and outcomes associated with blood transfusion in patients with septic shock. Intensive Care Med 2011, 37:S6-314.
21. Russell JA, Walley KR, Singer J, Gordon AC, Hebert PC, Cooper DJ. Vasopressin versus norepinephrine infusion in patients with septic shock. N Engl J Med 2008, 358:877-887. 10.1056/NEJMoa067373, 18305265.
22. American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. Crit Care Med 1992, 20:864-874. 10.1097/00003246-199206000-00025, 1597042, American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference.
23. Heyland DK, Muscedere J, Drover J, Jiang X, Day AG. Persistent organ dysfunction plus death: a novel, composite outcome measure for critical care trials. Crit Care 2011, 15:R98. 10.1186/cc10110, 3219367, 21418560.
24. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey SF-36. Conceptual framework and item selection. Med Care 1992, 30:473-483. 10.1097/00005650-199206000-00002, 1593914.
25. Ware JE. SF-36 health survey update. Spine (Phila Pa 1976) 2000, 25:3130-3139.
26. Guidet B, Martinet O, Boulain T, Philippart F, Poussel JF, Maizel J. Assessment of hemodynamic efficacy and safety of 6% hydroxyethylstarch 130/0.4 vs. 0.9% NaCl fluid replacement in patients with severe sepsis: The CRYSTMAS study. Crit Care 2012, 16:R94. 10.1186/cc11358, 3580640, 22624531.
27. Myburgh JA, Finfer S, Bellomo R, Billot L, Cass A, Gattas D. Hydroxyethyl starch or saline for fluid resuscitation in intensive care. N Engl J Med 2012, 367:1901-1911. 10.1056/NEJMoa1209759, 23075127.
28. Carlsen S, Perner A. Initial fluid resuscitation of patients with septic shock in the intensive care unit. Acta Anaesthesiol Scand 2011, 55:394-400. 10.1111/j.1399-6576.2011.02399.x, 21342150.
29. Smith SH, Perner A. Higher vs. lower fluid volume for septic shock: clinical characteristics and outcome in unselected patients in a prospective, multicenter cohort. Crit Care 2012, 16:R76. 10.1186/cc11333, 3580618, 22568926.
30. Wetterslev J, Thorlund K, Brok J, Gluud C. Trial sequential analysis may establish when firm evidence is reached in cumulative meta-analysis. J Clin Epidemiol 2008, 61:64-75. 10.1016/j.jclinepi.2007.03.013, 18083463.
31. Lan KKG, Demets DL. Discrete Sequential Boundaries for Clinical Trials. Biometrika 1983, 70:659-63.
32. Haybittle JL. Repeated assessment of results in clinical trials of cancer treatment. British J Rad 1971, 44:793-797.
33. Wetterslev J, Thorlund K, Brok J, Gluud C. Estimating required information size by quantifying diversity in random-effects model meta-analyses. BMC Med Res Methodol 2009, 9:86. 10.1186/1471-2288-9-86, 2809074, 20042080.
34. Bennett JA, Riegel B, Bittner V, Nichols J. Validity and reliability of the NYHA classes for measuring research outcomes in patients with cardiac disease. Heart Lung 2002, 31:262-270. 10.1067/mhl.2002.124554, 12122390.
35. Le Gall JR, Lemeshow S, Saulnier F. A new Simplified Acute Physiology Score (SAPS II) based on a European/North American multicenter study. JAMA 1993, 270:2957-2963. 10.1001/jama.1993.03510240069035, 8254858.
36. Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (sepsis-related organ failure assessment) score to describe organ dysfunction/failure. On behalf of the working group on sepsis-related problems of the European Society of Intensive Care Medicine. Intensive Care Med 1996, 22:707-710. 10.1007/BF01709751, 8844239.
37. Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K. SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials. Ann Intern Med 2013, 158:200-207. 10.7326/0003-4819-158-3-201302050-00583, 23295957.
38. Kahan BC, Morris TP. Reporting and analysis of trials using stratified randomisation in leading medical journals: review and reanalysis. BMJ 2012, 345:e5840. 10.1136/bmj.e5840, 3444136, 22983531.
39. Kahan BC, Morris TP. Improper analysis of trials randomised using stratified blocks or minimisation. Stat Med 2012, 31:328-340. 10.1002/sim.4431, 22139891.
40. ICH-GCP International Conference on Harmonisation of thecnical requirements for registration of pharmaceuticals for human use. [http://ichgcp.net/], ICH-GCP.
41. 59th WMA General Assembly WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. http://www.wma.net/en/30publications/10policies/b3/], 59th WMA General Assembly.
42. International Committee of Medical Jourjal Editors Uniform Requirements for Manuscripts Submitted to Biomedica. [http://www.icmje.org/], International Committee of Medical Jourjal Editors.
43. Carson JL, Grossman BJ, Kleinman S, Tinmouth AT, Marques MB, Fung MK, Holcomb JB, Illoh O, Kaplan LJ, Katz LM, Rao SV, Roback JD, Shander A, Tobian AA, Weinstein R, Swinton McLaughlin LG, Djulbegovic B. Clinical Transfusion Medicine Committee of the AABB: Red blood cell transfusion: a clinical practice guideline from the AABB*. Ann Intern Med 2012, 157:49-58. 10.7326/0003-4819-157-1-201206190-00429, 22751760.
44. Villanueva C, Colomo A, Bosch A, Concepción M, Hernandez-Gea V, Aracil C, Graupera I, Poca M, Alvarez-Urturi C, Gordillo J, Guarner-Argente C, Santaló M, Muñiz E, Guarner C. Transfusion strategies for acute upper gastrointestinal bleeding. N Engl J Med 2013, 368:11-21. 10.1056/NEJMoa1211801, 23281973.