Transfusion of red cells in hematopoietic stem cell transplantation (TRIST): study protocol for a randomized controlled trial

Trials

David Allan²  Dean Fergusson¹  Alan Tinmouth¹  Jason Tay¹ 

[1] Transfusion Research Centre, University of Ottawa and Clinical Epidemiology Program, Ottawa Hospital Research Institute, The Ottawa Hospital, Ottowa, Canada;The Ottawa Hospital Blood and Marrow Programme, The Ottawa Hospital, Ottowa, Canada

关键词: Pilot;    Randomized Clinical Trial;    Triggers;    Erythrocyte;    Red cell transfusion;    Hematopoietic Stem Cell Transplant;   

Others  :  1095854
DOI  :  10.1186/1745-6215-12-207

 received in 2011-08-09, accepted in 2011-09-21,  发布年份 2011

【 摘 要 】

Background

Insight regarding transfusion practices in Hematopoietic Stem cell Transplantation (HSCT) are lacking and the impact of red cell transfusion in this high risk group on outcomes following HSCT are not well appreciated. Red blood cell transfusion can be life-saving, however, liberal use of transfusion in critically ill patients failed to demonstrate significant clinical benefit. A large number of other observational studies have also demonstrated an association between red blood cell transfusions and increased morbidity such as infections and multi organ failure as well as increased mortality. The role of red cell transfusion on the clinical outcomes observed in patients undergoing HSCT remains poorly understood and a prospective randomized study of transfusion is required to gain insight and knowledge on best transfusion practices in this high risk population.

Methods

This report describes the design and methodological issues of a randomized pilot study evaluating red cell transfusion triggers in the setting of Hematopoietic Stem Cell Transplantation. This study has been funded by a peer review grant from the Canadian Blood Services and is registered on Clinicaltrials.gov NCT01237639.

Results

In 3 Canadian centres, 100 patients undergoing Hematopoietic Stem Cell Transplantation will be randomized to either a restrictive (target hemoglobin of 70-90 g/L) or liberal (target hemoglobin of 90-110 g/L) red cell transfusion strategy, based daily hemoglobin values up to 100 days post-transplant. The study will stratify participants by centre and type of transplant. The primary goal is to demonstrate study feasibility and we will collect clinical outcomes on 1) Transfusion Requirements, 2) Transplant Related Mortality, 3) Maximum grade of acute Graft versus Host Disease, 4) Veno-occlusive Disease, 5) Serious Infections, 6) Bearman Toxicity Score, 7) Bleeding, 8) Quality of Life, 9) Number of Hospitalizations and 10) Number of Intensive Care Unit (ICU) Admissions.

Conclusion

Upon completion, this pilot trial will provide preliminary insight into red cell transfusion practice and its influence in hematopoietic stem cell transplant outcomes. The results of this trial will inform the conduct of a larger study.

【 授权许可】

   
2011 Tay et al; licensee BioMed Central Ltd.

【 参考文献 】

• [1]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.
• [2]Xenocostas A, Yee A, Wong CJ, Sutton DM, Lipton JH, Kiss TL, Messner HA: RBC transfusion requirements after allogeneic marrow transplantation: impact of the before-transplant Hb level on transfusion and early survival. Transfusion 2003, 43:373-382.
• [3]Tinmouth A, Hutton B, Fergusson D, Huebsch L, McDiarmid S, Toze C, Roy J, Messner H: Effect Of Pre-Transplant Hemoglobin And Platelet Counts On Transfusion Requirements And Survival In Allogeneic Stem Cell Transplantation [abstract]. Transfusion 2005, 45:141A.
• [4]Kasbia G, Al-Gahtani F, Tay J, Labonte L, Tinmouth A, Ramsay T, Gillingham A, Yang L, Halpenny M, Giulivi A, McDiarmid S, Huebsch L, Allan DS: Reduced hemoglobin on day of peripheral blood progenitor cell collection is associated with low graft content of vascular progenitors and increased toxicity after autologous hematopoietic stem cell transplantation. Transfusion 2008, 48:2421-2428.
• [5]Khorana AA, Francis CW, Blumberg N, Culakova E, Refaai MA, Lyman GH: Blood transfusions, thrombosis, and mortality in hospitalized patients with cancer. Arch Intern Med 2008, 168:2377-2381.
• [6]Lacroix J, Hebert PC, Hutchison JS, Hume HA, Tucci M, Ducruet T, Gauvin F, Collet JP, Toledano BJ, Robillard P, Joffe A, Biarent D, Meert K, Peters MJ: Transfusion strategies for patients in pediatric intensive care units. N Engl J Med 2007, 356:1609-1619.
• [7]Kirpalani H, Whyte RK, Andersen C, Asztalos EV, Heddle N, Blajchman MA, Peliowski A, Rios A, LaCorte M, Connelly R, Barrington K, Roberts RS: The Premature Infants in Need of Transfusion (PINT) study: a randomized, controlled trial of a restrictive (low) versus liberal (high) transfusion threshold for extremely low birth weight infants. J Pediatr 2006, 149:301-307.
• [8]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.
• [9]de Souza SS, Camargos AF, Ferreira MC, de Assis Nunes PF, de Rezende CP, Araujo CA, Silva Filho AL: Hemoglobin levels predict quality of life in women with heavy menstrual bleeding. Arch Gynecol Obstet 2010, 281:895-900.
• [10]Adams KF Jr, Pina IL, Ghali JK, Wagoner LE, Dunlap SH, Schwartz TA, Stough WG, Mehra MR, Felker GM, Chiong JR, Patterson JH, Kim J, Butler J, Oren RM: Prospective evaluation of the association between hemoglobin concentration and quality of life in patients with heart failure. Am Heart J 2009, 158:965-971.
• [11]Clement FM, Klarenbach S, Tonelli M, Johnson JA, Manns BJ: The impact of selecting a high hemoglobin target level on health-related quality of life for patients with chronic kidney disease: a systematic review and meta-analysis. Arch Intern Med 2009, 169:1104-1112.
• [12]Kallich J, McDermott A, Xu X, Fayers P, Cella D: The relationship between patient knowledge of hemoglobin levels and health-related quality of life. Qual Life Res 2006, 15:57-68.
• [13]Lind M, Vernon C, Cruickshank D, Wilkinson P, Littlewood T, Stuart N, Jenkinson C, Grey-Amante P, Doll H, Wild D: The level of haemoglobin in anaemic cancer patients correlates positively with quality of life. Br J Cancer 2002, 86:1243-1249.
• [14]Przepiorka D, Weisdorf D, Martin P, Klingemann HG, Beatty P, Hows J, Thomas ED: 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant 1995, 15:825-828.
• [15]McDonald GB, Sharma P, Matthews DE, Shulman HM, Thomas ED: Venocclusive disease of the liver after bone marrow transplantation: diagnosis, incidence, and predisposing factors. Hepatology 1984, 4:116-122.
• [16]Garner JS, Jarvis WR, Emori TG, Horan TC, Hughes JM: CDC definitions for nosocomial infections, 1988. Am J Infect Control 1988, 16:128-140.
• [17]Bearman SI, Appelbaum FR, Buckner CD, Petersen FB, Fisher LD, Clift RA, Thomas ED: Regimen-related toxicity in patients undergoing bone marrow transplantation. J Clin Oncol 1988, 6:1562-1568.
• [18]Webert KE, Cook RJ, Couban S, Carruthers J, Lee KA, Blajchman MA, Lipton JH, Brandwein JM, Heddle NM: A multicenter pilot-randomized controlled trial of the feasibility of an augmented red blood cell transfusion strategy for patients treated with induction chemotherapy for acute leukemia or stem cell transplantation. Transfusion 2008, 48:81-91.
• [19]Rabin R, de CF: EQ-5D: a measure of health status from the EuroQol Group. Ann Med 2001, 33:337-343.
• [20]McQuellon RP, Russell GB, Cella DF, Craven BL, Brady M, Bonomi A, Hurd DD: Quality of life measurement in bone marrow transplantation: development of the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) scale. Bone Marrow Transplant 1997, 19:357-368.
• [21]Good Clinical Practice: Consolidated Guideline [http:/ / www.hc-sc.gc.ca/ dhp-mps/ prodpharma/ applic-demande/ guide-ld/ ich/ efficac/ e6-eng.php#a2.0] webcite 2011.
• [22]Interagency Advisory Panel on Research Ethics[http://www.pre.ethics.gc.ca] webcite 2011.