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

Volumn 48, Issue 1, 2008, Pages 81-91

  Webert, Kathryn E ^a   Cook, Richard J ^b   Couban, Stephen ^b   Carruthers, Julie ^b   Lee, Ker Ai ^b   Blajchman, Morris A ^b   Lipton, Jeffrey H ^b   Brandwein, Joseph M ^b   Heddle, Nancy M ^b  

^a MCMASTER UNIVERSITY   (Canada)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

HEMOGLOBIN;

ACUTE LEUKEMIA; ADULT; AGED; ANEMIA; ARTICLE; BLEEDING; CANADA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; ERYTHROCYTE TRANSFUSION; FEMALE; HEMOGLOBIN BLOOD LEVEL; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PARALLEL DESIGN; PILOT STUDY; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; RISK FACTOR; SINGLE BLIND PROCEDURE; STEM CELL TRANSPLANTATION; THROMBOCYTE TRANSFUSION; THROMBOCYTOPENIA;

ACUTE DISEASE; ADULT; AGED; ANTINEOPLASTIC AGENTS; ERYTHROCYTE TRANSFUSION; FEASIBILITY STUDIES; FEMALE; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HEMOGLOBINS; HEMORRHAGE; HUMANS; LEUKEMIA; MALE; MIDDLE AGED; PILOT PROJECTS;

EID: 37549062237     PISSN: 00411132     EISSN: 15372995     Source Type: Journal    
DOI: 10.1111/j.1537-2995.2007.01485.x     Document Type: Article

References (71)

1. Gaydos LA, Freireich EJ, Mantel N. The quantitative relation between platelet count and hemorrhage in patients with acute leukemia. N Engl J Med 1962 266 : 905 9.
2. Rebulla P, Finazzi G, Marangoni F, Avvisati G, Gugliotta L, Tognoni G, Barbui T, Mandelli F, Sirchia G. The threshold for prophylactic platelet transfusions in adults with acute myeloid leukemia. Gruppo Italiano Malattie Ematologiche Maligne dell'Adulto. N Engl J Med 1997 337 : 1870 5.
3. Leukocyte reduction and ultraviolet B irradiation of platelets to prevent alloimmunization and refractoriness to platelet transfusions. The Trial to Reduce Alloimmunization to Platelets Study Group. N Engl J Med 1997 337 : 1861 9.
4. Heddle NM, Blajchman MA, Meyer RM, Lipton JH, Walker IR, Sher GD, Constantini LA, Patterson B, Roberts RS, Thorpe KE, Levine MN. A randomized controlled trial comparing the frequency of acute reactions to plasma-removed platelets and prestorage WBC-reduced platelets. Transfusion 2002 42 : 556 66.
5. Nevo S, Swan V, Enger C, Wojno KJ, Bitton R, Shabooti M, Fuller AK, Jones RJ, Braine HG, Vogelsang GB. Acute bleeding after bone marrow transplantation (BMT)-incidence and effect on survival. A quantitative analysis in 1402 patients. Blood 1998 91 : 1469 77.
6. McCullough J, Vesole DH, Benjamin RJ, Slichter SJ, Pineda A, Snyder E, Stadtmauer EA, Lopez-Plaza I, Coutre S, Strauss RG, Goodnough LT, Fridey JL, Raife T, Cable R, Murphy S, Howard F Davis K, Lin JS, Metzel P, Corash L, Koutsoukos A, Lin L, Buchholz DH, Conlan MG. Therapeutic efficacy and safety of platelets treated with a photochemical process for pathogen inactivation: the SPRINT Trial. Blood 2004 104 : 1534 41.
7. Nevo S, Enger C, Hartley E, Borinsky ME, Swan V, Fuller AK, Braine HG, Kickler TS, George JN, Vogelsang GB. Acute bleeding and thrombocytopenia after bone marrow transplantation. Bone Marrow Transplant 2001 27 : 65 72.
8. Nevo S, Vogelsang GB. Acute bleeding complications in patients after bone marrow transplantation. Curr Opin Hematol 2001 8 : 319 25.
9. Ruttmann TG, James MF, Viljoen JF. Haemodilution induces a hypercoagulable state. Br J Anaesth 1996 76 : 412 4.
10. Kretschmer V, Daraktchiev A, Bade S, Karger R, Kratzer MA. Does hemodilution enhance coagulability? Anasthesiol Intensivmed Notfallmed Schmerzther 2004 39 : 751 6.
11. Blajchman MA, Bordin JO, Bardossy L, Heddle NM. The contribution of the haematocrit to thrombocytopenic bleeding in experimental animals. Br J Haematol 1994 86 : 347 50.
12. Escolar G, Garrido M, Mazzara R, Castillo R, Ordinas A. Experimental basis for the use of red cell transfusion in the management of anemic-thrombocytopenic patients. Transfusion 1988 28 : 406 11.
13. Uijttewaal WS, Nijhof EJ, Bronkhorst PJ, Den Hartog E, Heethaar RM. Near-wall excess of platelets induced by lateral migration of erythrocytes in flowing blood. Am J Physiol 1993 264 : H1239 44.
14. Hellem AJ, Borchgrevink CF, Ames SB. The role of red cells in haemostasis: the relation between haematocrit, bleeding time and platelet adhesiveness. Br J Haematol 1961 7 : 42 50.
15. Turitto VT, Weiss HJ. Red blood cells: their dual role in thrombus formation. Science 1980 207 : 541 3.
16. Aarts PA, Bolhuis PA, Sakariassen KS, Heethaar RM, Sixma JJ. Red blood cell size is important for adherence of blood platelets to artery subendothelium. Blood 1983 62 : 214 7.
17. Saniabadi AR, Lowe GD, Barbenel JC, Forbes CD. A comparison of spontaneous platelet aggregation in whole blood with platelet rich plasma: additional evidence for the role of ADP. Thromb Haemost 1984 51 : 115 8.
18. Boneu B, Fernandez F. The role of the hematocrit in bleeding. Transfus Med 1987 1 : 182 5.
19. Valles J, Santos MT, Aznar J, Marcus AJ, Martinez-Sales V, Portoles M, Broekman MJ, Safier LB. Erythrocytes metabolically enhance collagen-induced platelet responsiveness via increased thromboxane production, adenosine diphosphate release, and recruitment. Blood 1991 78 : 154 62.
20. Santos MT, Valles J, Aznar J, Perez-Requejo JL. Role of red blood cells in the early stages of platelet activation by collagen. Thromb Haemost 1986 56 : 376 81.
21. Santos MT, Valles J, Marcus AJ, Safier LB, Broekman MJ, Islam N, Ullman HL, Eiroa AM, Aznar J. Enhancement of platelet reactivity and modulation of eicosanoid production by intact erythrocytes. A new approach to platelet activation and recruitment. J Clin Invest 1991 87 : 571 80.
22. Lee DH, Bardossy L, Peterson N, Blajchman MA. o-Raffinose cross-linked hemoglobin improves the hemostatic defect associated with anemia and thrombocytopenia in rabbits. Blood 2000 96 : 3630 6.
23. Small M, Lowe GD, Cameron E, Forbes CD. Contribution of the haematocrit to the bleeding time. Haemostasis 1983 13 : 379 84.
24. Fernandez F, Goudable C, Sie P, Ton-That H, Durand D, Suc JM, Boneu B. Low haematocrit and prolonged bleeding time in uraemic patients: effect of red cell transfusions. Br J Haematol 1985 59 : 139 48.
25. Livio M, Gotti E, Marchesi D, Mecca G, Remuzzi G, de Gaetano G. Uraemic bleeding: role of anaemia and beneficial effect of red cell transfusions. Lancet 1982 2 : 1013 5.
26. Vigano G, Benigni A, Mendogni D, Mingardi G, Mecca G, Remuzzi G. Recombinant human erythropoietin to correct uremic bleeding. Am J Kidney Dis 1991 18 : 44 9.
27. Ho CH. The hemostatic effect of packed red cell transfusion in patients with anemia. Transfusion 1998 38 : 1011 4.
28. Ho CH. The hemostatic effect of adequate red cell transfusion in patients with anemia and thrombocytopenia. Transfusion 1996 36 : 290.
29. Martinowitz U, Goor DA, Ramot B, Mohr R. Is transfusion of fresh plasma after cardiac operations indicated? J Thorac Cardiovasc Surg 1990 100 : 92 8.
30. Mohr R, Martinowitz U, Lavee J, Amroch D, Ramot B, Goor DA. The hemostatic effect of transfusing fresh whole blood versus platelet concentrates after cardiac operations. J Thorac Cardiovasc Surg 1988 96 : 530 4.
31. Valeri CR, Cassidy G, Pivacek LE, Ragno G, Lieberthal W, Crowley JP, Khuri SF, Loscalzo J. Anemia-induced increase in the bleeding time: implications for treatment of nonsurgical blood loss. Transfusion 2001 41 : 977 83.
32. Berezina TL, Zaets SB, Morgan C, Spillert CR, Kamiyama M, Spolarics Z, Deitch EA, Machiedo GW. Influence of storage on red blood cell rheological properties. J Surg Res 2002 102 : 6 12.
33. Slichter SJ. Relationship between platelet count and bleeding risk in thrombocytopenic patients. Transfus Med Rev 2004 18 : 153 67.
34. Heddle NM, Cook RJ, Webert KE, Sigouin C, Rebulla P. Methodologic issues in the use of bleeding as an outcome in transfusion medicine studies. Transfusion 2003 43 : 742 52.
35. Miller AB, Hoogstraten B, Staquet M, Winkler A. Reporting results of cancer treatment. Cancer 1981 47 : 207 14.
36. Circular of information. Ottawa : Canadian Blood Services 2004.
37. Lawless JF. Statistical models and methods for lifetime data. New York : Wiley 2003.
38. Cook RJ, Lawless JF. Marginal analysis of recurrent events and a terminating event. Stat Med 1997 16 : 911 24.
39. Ghosh D, Lin DY. Nonparametric analysis of recurrent events and death. Biometrics 2000 56 : 554 62.
40. Webert KE, Cook RJ, Couban S, Carruthers J, Heddle NM. A study of the agreement between patient self-assessment and study personnel assessment of bleeding symptoms. Transfusion 2006 46 : 1926 33.
41. Expert Working Group. Guidelines for red blood cell and plasma transfusion for adults and children. CMAJ 1997 156 : S1 24.
42. Murphy MF, Wallington TB, Kelsey P, Boulton F, Bruce M, Cohen H, Duguid J, Knowles SM, Poole G, Williamson LM British Committee for Standards in Haematology, Blood Transfusion Task Force. Guidelines for the clinical use of red cell transfusions. Br J Haematol 2001 113 : 24 31.
43. Hill SR, Carless PA, Henry DA, Carson JL, Hebert PC, McClelland DB, Henderson KM. Transfusion thresholds and other strategies for guiding allogeneic red blood cell transfusion. Cochrane Database Syst Rev 2002 2 CD002042.
44. Carson JL, Hill S, Carless P, Hebert P, Henry D. Transfusion triggers: a systematic review of the literature. Transfus Med 2002 16 : 187 99.
45. 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 7.
46. Bell EF, Strauss RG, Widness JA, Mahoney LT, Mock DM, Seward VJ, Cress GA, Johnson KJ, Kromer IJ, Zimmerman MB. Randomized trial of liberal versus restrictive guidelines for red blood cell transfusion in preterm infants. Pediatrics 2005 115 : 1685 91.
47. Carson JL, Terrin ML, Barton FB, Aaron R, Greenburg AG, Heck DA, Magaziner J, Merlino FE, Bunce G, McClelland B, Duff A, Noveck H. A pilot randomized trial comparing symptomatic vs. hemoglobin-level-driven red blood cell transfusions following hip fracture. Transfusion 1998 38 : 522 9.
48. 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 17.
49. Lacroix J, Hebert PC, Hutchinson JS, Hume HA, Tucci M, Ducruet T, Gauvin F, Collet JP, Toledano BJ, Robillard P, Joffe A, Biarent D, Meert K, Peters MJ TRIPICU Investigators; Canadian Critical Care Trials Group; Pediatric Acute Lung Injury and Sepsis Investigators Network. Transfusion strategies for patients in pediatric intensive care units. N Engl J Med 2007 356 : 1609 19.
50. Firkin FC, Hays EF, Cline MJ. Effect of hypertransfusion on granulopoiesis in bone marrow depression: studies in the irradiated mouse. Br J Haematol 1977 35 : 225 31.
51. Smith PJ, Jackson CW, Dow LW, Edwards CC, Whidden MA. Effect of hypertransfusion on bone marrow regeneration in sublethally irradiated mice. I. Enhanced granulopoietic recovery. Blood 1980 56 : 52 7.
52. de Montpellier C, Cornu G, Rodhain J, Sokal G, Symann M. Myeloid stem cell kinetics in children hypertransfused during remission induction of acute lymphoblastic leukemia. Blood Cells 1982 8 : 439 44.
53. Smith PJ, Jackson CW, Whidden MA, Edwards CC. Effect of hypertransfusion on bone marrow regeneration in sublethally irradiated mice. II. Enhanced recovery of megakaryocytes and platelets. Blood 1980 56 : 58 63.
54. Toogood IR, Ekert H, Smith PJ. Controlled study of hypertransfusion during remission induction in childhood acute lymphocytic leukaemia. Lancet 1978 2 : 862 4.
55. Smith PJ, Ekert H. Evidence of stem-cell competition in children with malignant disease. A controlled study of hypertransfusion. Lancet 1976 1 : 776 9.
56. Lam WK, So SY, Ng RP, Yu DY. Can hypertransfusion attenuate myelosuppression associated with combination chemotherapy in patients with inoperable bronchogenic carcinoma? A report of a randomised, controlled study. Med Oncol 1983 11 : 343 6.
57. Ross SD, Fahrbach K, Frame D, Scheye R, Connelly JE, Glaspy J. The effect of anemia treatment on selected health-related quality-of-life domains: a systematic review. Clin Ther 2003 25 : 1786 805.
58. Sabbatini P. The relationship between anemia and quality of life in cancer patients. Oncologist 2000 5 Suppl 2 : 19 23.
59. Smith RE Jr. Erythropoietic agents in the management of cancer patients. Part 1: anemia, quality of life, and possible effects on survival. J Support Oncol 2003 1 : 249 56, 258 9.
60. Osterborg A, Brandberg Y, Molostova V, Iosava G, Abdulkadyrov K, Hedenus M, Messinger D. Randomized, double-blind, placebo-controlled trial of recombinant human erythropoietin, epoetin Beta, in hematologic malignancies. J Clin Oncol 2002 20 : 2486 94.
61. Littlewood TJ, Kallich JD, San Miguel J, Hendricks L, Hedenus M. Efficacy of darbepoetin alfa in alleviating fatigue and the effect of fatigue on quality of life in anemic patients with lymphoproliferative malignancies. J Pain Symptom Manage 2006 31 : 317 25.
62. Xenocostas A, Yee A, Wong CJ, Sutton DMC, 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 82.
63. Hebert PC, Wells G, Blajchman MA, 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 for the Canadian Critical Care Trials Group [published erratum appears in N Engl J Med 1999;340:1056]. N Engl J Med 1999 340 : 409 17.
64. Rao SV, Jollis JG, Harrington RA, Granger CB, Newby LK, Armstrong PW, Moliterno DJ, Lindblad L, Pieper K, Topol EJ, Stamler JS, Califf RM. Relationship of blood transfusion and clinical outcomes in patients with acute coronary syndromes. JAMA 2004 292 : 1555 62.
65. Vincent JL, Baron JF, Reinhart K, Gattinoni L, Thijs L, Webb A, Meier-Hellmann A, Nollet G, Peres-Bota D ABC (Anemia and Blood Transfusion in Critical Care) Investigators. Anemia and blood transfusion in critically ill patients. JAMA 2002 288 : 1499 507.
66. Corwin HL, Gettinger A, Pearl RG, Fink MP, Levy AM, Abraham E, MacIntyre NR, Shabot M, Dun MS, Shapiro MJ. 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.
67. Eikelboom JW, Mehta SR, Anand SS, Xie C, Fox KA, Yusuf S. Adverse impact of bleeding on prognosis in patients with acute coronary syndromes. Circulation 2006 114 : 774 82.
68. Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract 2004 10 : 307 12.
69. Baird C. Taking the mystery out of research: the pilot study. Orthop Nurs 2000 19 : 42 3.
70. van Teijlingen E, Hundley V. The importance of pilot studies. Nurs Stand 2002 16 : 33 6.
71. Gardner G, Gardner A, MacLellan L, Osborne S. Reconceptualising the objectives of a pilot study for clinical research. Int J Nurs Stud 2003 40 : 719 24.