Transfusion Medicine Reviews
Volume 23, Issue 1 , Pages 55-61 , January 2009

The Age of Red Blood Cells in Premature Infants (ARIPI) Randomized Controlled Trial: Study Design

  • Dean Fergusson

      Affiliations

    • Corresponding Author InformationAddress reprint requests to Dean Fergusson, MHA, PhD, Clinical Epidemiology Program, The Ottawa Hospital, 501 Smyth Rd, Box 201, Ottawa, Ontario, Canada K1H 8L6.
    • Authors DF, BH, DH, MB, PH, LK, SL, KS, SS, AT and RW all provided significant contributions to the development of the study protocol in its development phase, and all are involved in this ongoing study in the role of either site investigator, site coordinator or steering committee member.
    • ,
  • Brian Hutton

      Affiliations

    • Authors DF, BH, DH, MB, PH, LK, SL, KS, SS, AT and RW all provided significant contributions to the development of the study protocol in its development phase, and all are involved in this ongoing study in the role of either site investigator, site coordinator or steering committee member.
    • ,
  • Debora L. Hogan

      Affiliations

    • Authors DF, BH, DH, MB, PH, LK, SL, KS, SS, AT and RW all provided significant contributions to the development of the study protocol in its development phase, and all are involved in this ongoing study in the role of either site investigator, site coordinator or steering committee member.
    • ,
  • Louise LeBel
    • ,
  • Morris A. Blajchman

      Affiliations

    • Authors DF, BH, DH, MB, PH, LK, SL, KS, SS, AT and RW all provided significant contributions to the development of the study protocol in its development phase, and all are involved in this ongoing study in the role of either site investigator, site coordinator or steering committee member.
    • ,
  • Jason C. Ford
    • ,
  • Paul Hebert

      Affiliations

    • Authors DF, BH, DH, MB, PH, LK, SL, KS, SS, AT and RW all provided significant contributions to the development of the study protocol in its development phase, and all are involved in this ongoing study in the role of either site investigator, site coordinator or steering committee member.
    • ,
  • Ashok Kakadekar
    • ,
  • Lajos Kovacs

      Affiliations

    • Authors DF, BH, DH, MB, PH, LK, SL, KS, SS, AT and RW all provided significant contributions to the development of the study protocol in its development phase, and all are involved in this ongoing study in the role of either site investigator, site coordinator or steering committee member.
    • ,
  • Shoo Lee

      Affiliations

    • Authors DF, BH, DH, MB, PH, LK, SL, KS, SS, AT and RW all provided significant contributions to the development of the study protocol in its development phase, and all are involved in this ongoing study in the role of either site investigator, site coordinator or steering committee member.
    • ,
  • Koravangattu Sankaran

      Affiliations

    • Authors DF, BH, DH, MB, PH, LK, SL, KS, SS, AT and RW all provided significant contributions to the development of the study protocol in its development phase, and all are involved in this ongoing study in the role of either site investigator, site coordinator or steering committee member.
    • ,
  • Stan Shapiro

      Affiliations

    • Authors DF, BH, DH, MB, PH, LK, SL, KS, SS, AT and RW all provided significant contributions to the development of the study protocol in its development phase, and all are involved in this ongoing study in the role of either site investigator, site coordinator or steering committee member.
    • ,
  • John A. Smyth
    • ,
  • Kuppuchipalayam Ramesh
    • ,
  • Nicole Rouvinez Bouali
    • ,
  • Alan Tinmouth

      Affiliations

    • Authors DF, BH, DH, MB, PH, LK, SL, KS, SS, AT and RW all provided significant contributions to the development of the study protocol in its development phase, and all are involved in this ongoing study in the role of either site investigator, site coordinator or steering committee member.
    • ,
  • Robin Walker

      Affiliations

    • Authors DF, BH, DH, MB, PH, LK, SL, KS, SS, AT and RW all provided significant contributions to the development of the study protocol in its development phase, and all are involved in this ongoing study in the role of either site investigator, site coordinator or steering committee member.

References 

  1. Chin-Yee I, Arya N, D'Almeida M. The red cell storage lesion and its implication for transfusion. Transfus Sci. 1997;18:447–458
  2. Wolfe LC. The membrane and the lesions of storage in preserved red cells. Transfusion. 1985;25:185–203
  3. Card RT. Red cell membrane changes during storage. Transfus Med Rev. 1988;2:40–47
  4. Tinmouth A, Chin-Yee I. The clinical consequences of the red cell storage lesion. Transfus Med Rev. 2001;15:91–107
  5. Reynolds JD, Ahearn GS, Angelo M, et al. S-nitrosohemoglobin deficiency: A mechanism for loss of physiological activity in banked blood. Proc Natl Acad Sci. 2007;104:17058–17062
  6. Bennett-Guerrero EB, Veldman TH, Doctor A, et al. Evolution of adverse changes in stored RBCs. Proc Natl Acad Sci. 2007;104:17063–17068
  7. Dennis RC, Hechtman HB, Berger RL, et al. Transfusion of 2,3-DPG-enriched red blood cells to improve cardiac function. Ann Thorac Surg. 1978;26:17–26
  8. Allard J, Silliman C, Ambruso D, et al. A model of transfusion related acute lung injury (TRALI). Am J Respir Crit Care Med. 1996;153:[abstract]
  9. Strauss RG. Additive solutions and product age in neonatal red blood cell transfusion. In:  Herman JH,  Manno CS editor. Pediatric transfusion practice. Philadelphia (Pa): American Association of Blood Banks; 2002;p. 129–145
  10. Kleinman S, Chan P, Robillard P. Risks associated with transfusion of cellular blood components in Canada. Transfus Med Rev. 2003;17:120–162
  11. Fergusson D, Hebert PC, Lee SK, et al. Clinical outcomes following institution of universal leukoreduction of blood transfusions for premature infants. JAMA. 2003;289:1950–1956
  12. Boulton JE, et al. Changing transfusion practices in the NICU. Pediatr Res. 1995;197A;[abstract]
  13. Hume H, et al. Small volume red blood cell transfusions for neonatal patients. Transfus Med Rev Trans Med Rev. 1995;9:187–199
  14. Levy GJ, et al. National survey of neonatal transfusion practices: I. Red blood cell therapy. Pediatrics. 1993;91:523–529
  15. Strauss RG, et al. National survey of neonatal transfusion practices: II. Blood component therapy. Pediatrics. 1993;91:530–536
  16. Lee DS, Sesha M, Boulton J, et al. Variation in the incidence of necrotizing enterocolitis (NEC) in very-low-birth-weight infants among Canadian neonatal intensive care units. Pediatr Res. 2000;47:410A;[abstract]
  17. Ohlsson A, Synnes AR, Seshia MMK, et al. Variations in the site-specific rates of bronchopulmonary dysplasia (BPD) among infants admitted to 17 neonatal intensive care units (NICUs) in Canada—Implications for bench marking. Pediatr Res. 2000;47:371A
  18. Valeri CR, Hirsh NM. Restoration in vivo of erythrocyte adenosine triphosphate, 2.3-diphosphoglycerate, potassium ion, and sodium ion concentrations following the transfusion of acid-citrate-dextrose-stored human red blood cells. J Lab Clin Med. 1969;73:722–733
  19. Valeri CR, Collins FB. Physiologic effects of 2,3-DPG-depleted red cells with high affinity for oxygen. J Appl Physiol. 1971;31:823–827
  20. Chaplin HJ, Beutler E, Collins JA, et al. Current status of red-cell preservation and availability in relation to the development National Blood Policy. N Engl J Med. 1974;291:68–74
  21. Bunn HF, May MH, Kocholaty WF, et al. Hemoglobin function in stored blood. J Clin Invest. 1969;48:311–321
  22. Sugerman HJ, Davidson DT, Vibul S, et al. The basis of defective oxygen delivery from stored blood. Surg Gynecol Obstet. 1970;137:733–741
  23. Valeri CR, Collins FB. The physiologic effect of transfusing preserved red cells with low 2,3-diphosphoglycerate and high affinity for oxygen. Vox Sang. 1971;20:397–403
  24. Silliman C, Hiester AA. Plasma from stored red cells activate human pulmonary endothelial cells. Transfusion. 1998;38:96S;(suppl, abstr)
  25. Silliman C, Voelkel NF, Allard JD, et al. Plasma and lipids from stored packed red blood cells cause acute lung injury in an animal model. J Clin Invest. 1998;101:1458–1467
  26. Berezina TL, Zaets SB, Morgan C, et al. Influence of storage on red blood cell rheological properties. J Surg Res. 2002;102:6–12
  27. Marik PE, Sibbald WJ. Effect of stored-blood transfusion on oxygen delivery in patients with sepsis. JAMA. 1993;269:3024–3029
  28. Martin CM, Sibbald WJ, Lu X, et al. Age of transfused red blood cells is associated with ICU length of stay. Clin Invest Med. 1994;17:124
  29. Purdy FR, Tweeddale MG, Merrick PM. Association of mortality with age of blood transfused in septic ICU patients. Can J Anaesth. 1997;44:1256–1261
  30. Zallen G, Offner PJ, Moore EE, et al. Age of transfused blood is an independent risk factor for postinjury multiple organ failure. Am J Surg. 1999;178:570–572
  31. Vamvakas EC, Carven JH. Transfusion and postoperative pneumonia in coronary artery bypass graft surgery: Effect of the length of storage of transfused red cells. Transfusion. 1999;39:701–710
  32. Vamvakas EC, Carven JH. Transfusion and postoperative pneumonia in coronary artery bypass graft surgery: Effect of the length of storage of transfused red cells. Transfusion. 2000;40:101–109
  33. Walsh TS, McArdle F, MacIver C, et al. Age of stored red cells does not influence indices of oxygenation after transfusion to critically ill patients: Randomized controlled trial. Eur Soc Intensive Care Med. 2001;27:S247
  34. Offner PJ, Moore EE, Biffl WL, et al. Increased rate of infection associated with transfusion of old blood after severe injury. Arch Surg. 2002;137:267–272
  35. Leal-Noval SR, Jara-Lopez I, Garcia-Garmendia JL, et al. Influence of erythrocyte concentrate storage time on postsurgical morbidity in cardiac surgery patients. Anesthesiology. 2003;98:815–822
  36. Widness JA, Seward VJ, Jromer IJ, et al. Changing patterns of red blood cell transfusion in very-low-birth-weight infants. J Pediar. 1996;129:680–687
  37. Bifano EM, et al. Perinatal hematology. Clin Perinatol. 1995;545–835
  38. Fetus and Newborn Committee (Canadian Paediatric Society) . Guidelines for transfusion of erythrocytes to neonates and premature infants. CMAJ. 1992;147:1781–1792
  39. Hume HA, et al. Symposium on neonatal transfusions. Transfus Med Rev. 1995;9:185–287
  40. Strauss RG, Burmeister LF, Johnson K, et al. Feasibility and safety of AS-3 red blood cells for neonatal transfusions. J Pediatr. 2000;136:215–219
  41. Strauss RG, Burmeister LF, Johnson K, et al. AS-1 red blood cells for neonatal transfusions: A randomized trial assessing donor exposure and safety. Transfusion. 1996;36:873–878
  42. Liu EA, Mannino FL, Lane TA. Prospective, randomized trial of the safety and efficacy of a limited donor exposure transfusion program for premature neonates. J Pediatr. 1994;125:92–96
  43. Lee DA, Slagel TA, Jackson TM, et al. Reducing blood donor exposures in low-birth-weight infants by the use of older, unwashed packed red blood cells. J Pediatr. 1995;126:280–286
  44. Valtis DJ, Kennedy AC. Defective gas-transport function of stored red blood cells. Lancet. 1954;1:119–125
  45. Silvers KM, Gibson AT, Russell JM, et al. Antioxidant activity, packed cell transfusions, and outcome in premature infants. Arch Dis Child Fetal Neonatal Ed. 1998;78:f214–f219
  46. Dani C, Reali MF, Bertini G, et al. The role of blood transfusions and iron intake on retinopathy of prematurity. Early Hum Dev. 2001;62:57–63
  47. McGrady GA, Rettig PJ, Istre GR, et al. An outbreak of necrotizing enterocolitis. Association with transfusions of packed red blood cells. Am J Epidemiol. 1987;126:1165–1172
  48. Bell MJ, Ternberg JL, Feigin RD. Neonatal necrotizing enterocolitis. Therapeutic decisions based upon clinical staging. Ann Surg. 1978;187:1–7
  49. Papile LA. Incidence and evolution of subependymal and intraventricular hemorrhage. A study of infants with birth weights less than 1500 gm. J Pediatr. 1978;92:529–534
  50. Vamvakas EC, Blajchman MA. Transfusion-related immunomodulation (TRIM): An update. Blood Rev. 2007;21:327–348
  51. Lachin JM. Introduction to sample size determination and power analysis for clinical trials. Controlled Clin Trials. 1980;1:13–27

 This study has been funded by the Canadian Institutes of Health Research, Ottawa, Ontario, Canada.

PII: S0887-7963(08)00075-8

doi: 10.1016/j.tmrv.2008.09.005

Transfusion Medicine Reviews
Volume 23, Issue 1 , Pages 55-61 , January 2009

Article Tools

* Image Usage & Resolution