A multi-centre randomised controlled trial of Transfusion Indication Threshold Reduction on transfusion rates, morbidity and healthcare resource use following cardiac surgery: Study protocol

Transfusion and Apheresis Science

Volumn 50, Issue 3, 2014, Pages 451-461

  Brierley, Rachel C M ^a   Pike, Katie ^a   Miles, Alice ^a   Wordsworth, Sarah ^b   Stokes, Elizabeth A ^b   Mumford, Andrew D ^c   Cohen, Alan ^c   Angelini, Gianni D ^c   Murphy, Gavin J ^d   Rogers, Chris A ^a   Reeves, Barnaby C ^a  

^a UNIVERSITY OF BRISTOL   (United Kingdom)

^b UNIVERSITY OF OXFORD   (United Kingdom)

^c BRISTOL ROYAL INFIRMARY   (United Kingdom)

^d UNIVERSITY OF LEICESTER   (United Kingdom)

Author keywords

Cardiac surgery; Protocol; Red cell; Restrictive; Transfusion

Indexed keywords

CREATININE; HEMOGLOBIN;

ADOLESCENT; ADULT; ARTICLE; CLINICAL PROTOCOL; COST EFFECTIVENESS ANALYSIS; CREATININE BLOOD LEVEL; ECONOMIC EVALUATION; ERYTHROCYTE TRANSFUSION; FEMALE; FOLLOW UP; HEALTH CARE UTILIZATION; HEART SURGERY; HEMOGLOBIN BLOOD LEVEL; HOSPITALIZATION; HOSPITALIZATION COST; HUMAN; INFECTION RISK; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY (TOPIC); OUTCOME ASSESSMENT; PATIENT SAFETY; POSTOPERATIVE COMPLICATION; POSTOPERATIVE INFECTION; POSTOPERATIVE PERIOD; PREOPERATIVE PERIOD; QUALITY ADJUSTED LIFE YEAR; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); STUDY DESIGN; SURGICAL MORTALITY; SURGICAL RISK; TRANSFUSION RELATED ACUTE LUNG INJURY; TREATMENT INDICATION; WOUND ASSESSMENT; WOUND INFECTION; BLOOD; BLOOD TRANSFUSION; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED STUDY; GREAT BRITAIN; METABOLISM; MORTALITY; MULTICENTER STUDY; POSTOPERATIVE COMPLICATIONS; RANDOMIZED CONTROLLED TRIAL; RETROSPECTIVE STUDY; TIME FACTOR;

BLOOD TRANSFUSION; CARDIAC SURGICAL PROCEDURES; FEMALE; FOLLOW-UP STUDIES; GREAT BRITAIN; HEMOGLOBINS; HUMANS; MALE; POSTOPERATIVE COMPLICATIONS; RETROSPECTIVE STUDIES; TIME FACTORS;

EID: 84926098377     PISSN: 14730502     EISSN: 18781683     Source Type: Journal    
DOI: 10.1016/j.transci.2014.02.020     Document Type: Article

References (39)

1. Wells A.W., Mounter P.J., Chapman C.E., Stainsby D., Wallis J.P. Where does blood go? Prospective observational study of red cell transfusion in north England. BMJ 2002, 325:803.
2. Murphy G.J., Reeves B.C., Rogers C.A., et al. Increased mortality, post-operative morbidity and cost following red blood cell transfusion in patients having cardiac surgery. Circulation 2007, 116:2544-2552. Epub 2007 November 12.
3. Corwin H.L., Parsonnet K.C., Gettinger A. RBC transfusion in the ICU: is there a reason?. Chest 1995, 108:767-771.
4. Stover E.P., Siegel L.C., Parks R., Levin J., Body S.C., Maddi R., et al. Variability in transfusion practice for coronary artery bypass surgery persists despite national consensus guidelines: a 24-institution study. Institutions of the multicenter study of perioperative ischemia research group. Anesthesiology 1998, 88:327-333.
5. Regan F., Taylor C. Blood transfusion medicine. BMJ 2002, 325:143-147.
6. Spahn D.R., Casutt M. Eliminating blood transfusions: new aspects and perspectives. Anesthesiol 2000, 93:242-255.
7. Vamvakas E.C., Carven J.H. Transfusion and postoperative pneumonia in coronary artery bypass surgery: effect of the length of storage of transfused red cells. Transfusion 2000, 40:832-839.
8. Leal-Noval S.R., Marquez-Vácaro J.A., Garcia-Curiel A., et al. Nosocomial pneumonia in patients undergoing heart surgery. Crit Care Med 2000, 28:935-940.
9. Zacharias A., Habib R.H. Factors predisposing to median sternotomy complications. Deep vs superficial infection. Chest 1996, 110:1173-1178.
10. Michalopoulos A., Stavridis G., Geroulanos S. Severe sepsis in cardiac surgical patients. Eur J Surg 1998, 164:217-222.
11. Vincent J.L., Baron J.-F., Reinhart K., et al. Anemia and blood transfusion in critically ill patients. JAMA 2002, 288:1499-1507.
12. Engoren M.C., Habib R.H., Zacharias A., Schwann T.A., Riordan C.J., Durham S.J. Effect of blood transfusion on long-term survival after cardiac operation. Ann Thorac Surg 2002, 74:1180-1186.
13. Jensen L.S., Grunnet N., Hanberg Sorensen F., Jorgensen J. Cost-effectiveness of blood transfusion and white cell reduction in elective colorectal surgery. Transfusion 1995, 35:719-722.
14. Blumberg N., Kirkley S.A., Heal J.M. A cost analysis of autologous and allogeneic transfusions in hip-replacement surgery. Am J Surg 1996, 171:324-330.
15. Weiskopf R.B., Viele M.K., Feiner J., et al. Human cardiovascular and metabolic responseto acute, severe isovolemic anemia. JAMA 1998, 279:217-221.
16. Carson J.L., Hill S., Carless P., Hébert P.C., Henry D. Transfusion triggers: a systematic review of the literature. Trans Med Rev 2002, 16:187-199.
17. Carson J.L., Terrin M.L., Noveck H., Sanders D.W., Chaitman B.R., Rhoads G.G., et al. Liberal or restrictive transfusion in high-risk patients after hip surgery. N Engl J Med 2011, 365:2453-2462.
18. Hebert P.C., Wells G., Blajchman M.A., Marshall J., Martin C., Pagliarello G., et al. 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.
19. Hébert P.C., Yetisir E., Martin C., et al. Is a low transfusion threshold safe in critically ill patients with cardiovascular diseases?. Crit Care Med. 2001, 29:227-234.
20. Hill S.R., Carless P.A., Henry D.A., et al. Transfusion thresholds and other strategies for guiding allogeneic red blood cell transfusion. Cochrane Database Syst Rev 2000, (1). 10.1002/14651858.CD00204.
21. Murphy G.J., Allen S.M., Unsworth-White J., Lewis C.T., Dalrymple-Hay M.J.R. Laboratory coagulation and lytic parameters resulting from autotransfusion of washed salvaged red cells following coronary artery bypass grafting: a randomised controlled trial. Ann Thorac Surg 2004, 77:1553-1559.
22. Murphy GJ, Modi P, Allen SM, Unsworth-White J, Lewis CT, Dalrymple- Hay MJR. Economic outcome of perioperative cell salvage and autotransfusion following coronary artery bypass grafting: a randomised trial. Presented to the European Society of Cardiothoracic Surgeons September, 2004.
23. Hajjar L.A., Vincent J.-L., Galas F.R.B.G., et al. Transfusion requirements after cardiac surgery - the TRACS randomized controlled trial. JAMA 2010, 304:1559-1567.
24. Wilson A.P., Weavill C., Burridge J., Kelsey M.C. The use of the wound scoring method 'ASEPSIS' in postoperative wound surveillance. J Hosp Infect 1990, 16:297-309.
25. Gibbons C., Bruce J., Carpenter J., Wilson A.P., Wilson J., Pearson A., et al. Identification of risk factors by systematic review and development of risk-adjusted models for surgical site infection. Health Technol Assess 2011, 15(30):1-156. iii-iv.
26. EuroQol Group EuroQol - a new facility for the measurement of health-related quality of life. Health Policy 1990, 16:119-208.
27. Cohen J. Statistical power analysis for the behavioral sciences 1988, 24-27. Lawrence Erlbaum, New Jersey. 2nd ed.
28. Pike K, Nash RL, Murphy GJ, Reeves BC, Rogers CA. Update on the Transfusion Indication Threshold Reduction (TITRe2) trial in cardiac surgery: statistical analysis plan. Submitted for publication.
29. National Institute for Health and Care Excellence (NICE). A Guide to the Methods of Technology Appraisal. London, NICE, 2013. http://publications.nice.org.uk/guide-to-the-methods-of-technology-appraisal-2013.
30. Department of Health NHS Reference Costs 2011-12 2012, Department of Health, London.
31. Curtis L. Unit costs of health and social care 2012 2012, The University of Kent, Canterbury.
32. Kind P., Dolan P., Gudex C., Williams A. Variations in population health status: results from a United Kingdom national questionnaire survey. BMJ 1998, 316:736-741.
33. Briggs A., Clark T., Wolstenholme J., Clarke P. Missing presumed at random: cost-analysis of incomplete data. Health Econ 2003, 12(5):377-392.
34. National Institute for Health and Clinical Excellence. Social value judgements: Principles for the development of NICE guidance, In: 2nd ed., 2008. http://www.nice.org.uk/media/C18/30/SVJ2PUBLICATION2008.pdf.
35. Koch C.G., Li L., Duncan A.I., Mihaljevic T., Cosgrove D.M., Loop F.D., et al. Morbidity and mortality risk associated with red blood cell and blood-component transfusion in isolated coronary artery bypass grafting. Crit Care Med 2006, 34:1608-1616.
36. Walsh T.S., McClelland D.B.L. When should we transfuse critically ill and perioperative patients with known coronary artery disease. Br J Anaesth 2002, 89:719-722.
37. Shehata N., Burns L.A., Nathan H., Hebert P., Hare G.M.T., Fergusson D., et al. A randomized controlled pilot study of adherence to transfusion strategies in cardiac surgery. Transfusion 2012, 52:91-99.
38. Wilson A.P., Treasure T., Sturridge M.F., Gruneberg R.N. A scoring method (ASEPSIS) for postoperative wound infections for use in clinical trials of antibiotic prophylaxis. Lancet 1986, 1:311-313.
39. Mehta R.L., Kellum J.A., Shah S.V., Molitoris B.A., Ronco C., Warnock D.G., et al. Acute kidney injury network: report of an initiative to improve outcomes in acute kidney injury. Crit Care 2007, 11:R31.