Safety and effectiveness of a Patient Blood Management (PBM) program in surgical patients - the study design for a multi-centre prospective epidemiologic non-inferiority trial

BMC Health Services Research

Kai Zacharowski²  Erhard Seifried³  Björn Steffen⁴  Eva Herrmann¹  Christian Friedrich Weber²  Markus Matthias Müller³  Christof Geisen³  Dania Patricia Fischer²  Patrick Meybohm² 

[1]Institute of Biostatistics and Mathematical Modelling, University Hospital Frankfurt, Theodor-Stern-Kai 7, Frankfurt am Main, 60590, Germany

[2]Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Theodor-Stern-Kai 7, Frankfurt am Main, 60590, Germany

[3]German Red Cross Blood Transfusion Service Baden-Wuerttemberg – Hessen, Institute of Transfusion Medicine and Immunohematology, Sandhofstrasse 1, Frankfurt am Main, Germany

[4]Department of Haematooncology, University Hospital Frankfurt, Frankfurt am Main, Germany

关键词: Perioperative Care;    Clinical Outcome;    Anaemia;    Red Blood Cell Transfusion Practice, Patient Safety;    Patient Blood Management;   

Others  :  1091477
DOI  :  10.1186/s12913-014-0576-3

 received in 2014-03-13, accepted in 2014-11-03,  发布年份 2014

【 摘 要 】

Background

Preoperative and hospital-acquired anaemia is common among surgical patients. It is associated with an increased risk of morbidity and mortality and a strong risk factor for allogeneic blood transfusions with their own inherent risks. Patient Blood Management (PBM) concepts aim to increase and preserve autologous erythrocyte volume and to optimise haemotherapy. They thus have great potential to benefit patients.

Methods/Design

This prospective, multi-centre clinical trial tests the hypothesis that PBM programs are safe and effective in the care of adult surgical patients. Primary outcome is a composite endpoint of adverse events and in-hospital mortality.

Discussion

This trial will determine whether the implementation of a PBM program is safe and effective in terms of clinical outcome compared to a pre-implementation cohort. This trial is registered at www.clinicaltrials.gov webcite (NCT01820949).

【 授权许可】

   
2014 Meybohm et al.; licensee BioMed Central Ltd.

【 图 表 】

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【 参考文献 】

• [1]Musallam KM, Tamim HM, Richards T, Spahn DR, Rosendaal FR, Habbal A, Khreiss M, Dahdaleh FS, Khavandi K, Sfeir PM, Soweid A, Hoballah JJ, Taher AT, Jamali FR: Preoperative anaemia and postoperative outcomes in non-cardiac surgery: a retrospective cohort study. Lancet 2011, 378:1396-1407.
• [2]Koch CG, Li L, Sun Z, Hixson ED, Tang A, Phillips SC, Blackstone EH, Henderson JM: Hospital-acquired anemia: Prevalence, outcomes, and healthcare implications. J Hosp Med 2013, 8:506-512.
• [3]Marik PE, Corwin HL: Efficacy of red blood cell transfusion in the critically ill: a systematic review of the literature. Crit Care Med 2008, 36:2667-2674.
• [4]Shander A, Goodnough LT: Why an alternative to blood transfusion? Crit Care Clin 2009, 25:261-277.
• [5]Vamvakas EC, Blajchman MA: Transfusion-related mortality: the ongoing risks of allogeneic blood transfusion and the available strategies for their prevention. Blood 2009, 113:3406-3417.
• [6]Frank SM, Savage WJ, Rothschild JA, Rivers RJ, Ness PM, Paul SL, Ulatowski JA: Variability in blood and blood component utilization as assessed by an anesthesia information management system. Anesthesiology 2012, 117:99-106.
• [7]Bennett-Guerrero E, Zhao Y, O’Brien SM, Ferguson TB Jr, Peterson ED, Gammie JS, Song HK: Variation in use of blood transfusion in coronary artery bypass graft surgery. JAMA 2010, 304:1568-1575.
• [8]Farmer SL, Towler SC, Leahy MF, Hofmann A: Drivers for change: Western Australia Patient Blood Management Program (WA PBMP), World Health Assembly (WHA) and Advisory Committee on Blood Safety and Availability (ACBSA). Best Pract Res Clin Anaesthesiol 2013, 27:43-58.
• [9]Spahn DR, Goodnough LT: Alternatives to blood transfusion. Lancet 2013, 381:1855-1865.
• [10]Gombotz H, Zacharowski K, Spahn DR: Patient Blood Management: Individual treatment to reduce and prevent anaemia. 1st edition. ThiemeVerlag, Stuttgart; 2013.
• [11]Shander A, Van Aken H, Colomina MJ, Gombotz H, Hofmann A, Krauspe R, Lasocki S, Richards T, Slappendel R, Spahn DR: Patient blood management in Europe. Br J Anaesth 2012, 109:55-68.
• [12]Shander A, Goodnough LT, Javidroozi M, Auerbach M, Carson J, Ershler WB, Ghiglione M, Glaspy J, Lew I: Iron Deficiency Anemia-Bridging the Knowledge and Practice Gap. Transfus Med Rev 2014, 28:156-166.
• [13]Cross-sectional Guidelines for Therapy with Blood Components and Plasma Derivatives. 2008.
• [14]Fischer D, Zacharowski KD, Meybohm P: Savoring every drop - Vampire or Mosquito? Crit Care 2014, 18:306. BioMed Central Full Text
• [15]World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects Jama 2013, 310(20):2191-2194.
• [16]Glance LG, Dick AW, Mukamel DB, Fleming FJ, Zollo RA, Wissler R, Salloum R, Meredith UW, Osler TM: Association between intraoperative blood transfusion and mortality and morbidity in patients undergoing noncardiac surgery. Anesthesiology 2011, 114:283-292.
• [17]Acheson AG, Brookes MJ, Spahn DR: Effects of allogeneic red blood cell transfusions on clinical outcomes in patients undergoing colorectal cancer surgery: a systematic review and meta-analysis. Ann Surg 2012, 256:235-244.
• [18]Gombotz H: Patient blood management is key before elective surgery. Lancet 2011, 378:1362-1363.
• [19]Spahn DR, Moch H, Hofmann A, Isbister JP: Patient blood management: the pragmatic solution for the problems with blood transfusions. Anesthesiology 2008, 109:951-953.
• [20]Brevig J, McDonald J, Zelinka ES, Gallagher T, Jin R, Grunkemeier GL: Blood transfusion reduction in cardiac surgery: multidisciplinary approach at a community hospital. Ann Thorac Surg 2009, 87:532-539.
• [21]Kotze A, Carter LA, Scally AJ: Effect of a patient blood management programme on preoperative anaemia, transfusion rate, and outcome after primary hip or knee arthroplasty: a quality improvement cycle. Br J Anaesth 2012, 108:943-952.
• [22]Emmert MY, Salzberg SP, Theusinger OM, Felix C, Plass A, Hoerstrup SP, Falk V, Gruenenfelder J: How good patient blood management leads to excellent outcomes in Jehovah’s witness patients undergoing cardiac surgery. Interact Cardiovasc Thorac Surg 2011, 12:183-188.
• [23]Hofmann A, Farmer S, Towler SC: Strategies to preempt and reduce the use of blood products: an Australian perspective. Curr Opin Anaesthesiol 2012, 25:66-73.
• [24]Theusinger OM, Felix C, Spahn DR: Strategies to reduce the use of blood products: a European perspective. Curr Opin Anaesthesiol 2012, 25:59-65.