A No-Prophylaxis Platelet-Transfusion Strategy for Hematologic Cancers

被引：338

作者：

Stanworth, Simon J. ^{[1
,2
]}

Estcourt, Lise J. ^{[1
,2
]}

Powter, Gillian ^{[1
,6
]}

Kahan, Brennan C. ^{[4
]}

Dyer, Claire ^{[1
,6
]}

Choo, Louise ^{[4
]}

Bakrania, Lekha ^{[6
]}

Llewelyn, Charlotte ^{[6
]}

Littlewood, Timothy ^{[3
]}

Soutar, Richard ^{[7
]}

Norfolk, Derek ^{[8
]}

Copplestone, Adrian ^{[9
]}

Smith, Neil ^{[10
]}

Kerr, Paul ^{[11
]}

Jones, Gail ^{[12
]}

Raj, Kavita ^{[5
]}

Westerman, David A. ^{[16
]}

Szer, Jeffrey ^{[17
]}

Jackson, Nicholas ^{[13
]}

Bardy, Peter G. ^{[19
]}

Plews, Dianne ^{[14
]}

Lyons, Simon ^{[15
]}

Bielby, Linley ^{[18
]}

Wood, Erica M. ^{[16
,17
,18
]}

Murphy, Michael F. ^{[1
,2
]}

机构：

[1] John Radcliffe Hosp, NHS Blood & Transplant, Oxford Univ Hosp NHS Trust, Oxford OX3 9BQ, England

[2] Univ Oxford, Nuffield Dept Med, Oxford, England

[3] Churchill Hosp, Oxford Univ Hosp NHS Trust, Oxford OX3 7LJ, England

[4] MRC, Clin Trials Unit, London, England

[5] Guys & St Thomas Hosp, London SE1 9RT, England

[6] MRC, Clin Studies Unit, NHS Blood & Transplant, Cambridge, England

[7] Beatson West Scotland Canc Ctr, Glasgow, Lanark, Scotland

[8] Leeds Teaching Hosp, Leeds, W Yorkshire, England

[9] Plymouth Derriford Hosp, Plymouth, Devon, England

[10] Birmingham Heartlands Hosp, Birmingham B9 5ST, W Midlands, England

[11] Royal Devon & Exeter Hosp, Exeter EX2 5DW, Devon, England

[12] Freeman Rd Hosp, Newcastle Upon Tyne, Tyne & Wear, England

[13] Univ Hosp, Coventry, W Midlands, England

[14] James Cook Univ Hosp, Middlesbrough, Cleveland, England

[15] Sunderland City Hosp, Sunderland, England

[16] Peter MacCallum Canc Ctr, East Melbourne, Vic, Australia

[17] Royal Melbourne Hosp, Melbourne, Vic, Australia

[18] Australian Red Cross Blood Serv, Melbourne, Vic, Australia

[19] Royal Adelaide Hosp, Adelaide, SA 5000, Australia

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2013年 / 368卷 / 19期

关键词：

MALIGNANCIES; TRIAL;

D O I：

10.1056/NEJMoa1212772

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

BACKGROUND The effectiveness of platelet transfusions to prevent bleeding in patients with hematologic cancers remains unclear. This trial assessed whether a policy of not giving prophylactic platelet transfusions was as effective and safe as a policy of providing prophylaxis. METHODS We conducted this randomized, open-label, noninferiority trial at 14 centers in the United Kingdom and Australia. Patients were randomly assigned to receive, or not to receive, prophylactic platelet transfusions when morning platelet counts were less than 10x10(9) per liter. Eligible patients were persons 16 years of age or older who were receiving chemotherapy or undergoing stem-cell transplantation and who had or were expected to have thrombocytopenia. The primary end point was bleeding of World Health Organization (WHO) grade 2, 3, or 4 up to 30 days after randomization. RESULTS A total of 600 patients (301 in the no-prophylaxis group and 299 in the prophylaxis group) underwent randomization between 2006 and 2011. Bleeding of WHO grade 2, 3, or 4 occurred in 151 of 300 patients (50%) in the no-prophylaxis group, as compared with 128 of 298 (43%) in the prophylaxis group (adjusted difference in proportions, 8.4 percentage points; 90% confidence interval, 1.7 to 15.2; P = 0.06 for noninferiority). Patients in the no-prophylaxis group had more days with bleeding and a shorter time to the first bleeding episode than did patients in the prophylaxis group. Platelet use was markedly reduced in the no-prophylaxis group. A prespecified subgroup analysis identified similar rates of bleeding in the two study groups among patients undergoing autologous stem-cell transplantation. CONCLUSIONS The results of our study support the need for the continued use of prophylaxis with platelet transfusion and show the benefit of such prophylaxis for reducing bleeding, as compared with no prophylaxis. A significant number of patients had bleeding despite prophylaxis. (Funded by the National Health Service Blood and Transplant Research and Development Committee and the Australian Red Cross Blood Service; TOPPS Controlled-Trials. com number, ISRCTN08758735.)

引用

页码：1771 / 1780

页数：10

共 23 条

[11] Reporting and analysis of trials using stratified randomisation in leading medical journals: review and reanalysis [J].

Kahan, Brennan C. ;

Morris, Tim P. .

BMJ-BRITISH MEDICAL JOURNAL, 2012, 345

[12] Improper analysis of trials randomised using stratified blocks or minimisation [J].

Kahan, Brennan C. ;

Morris, Tim P. .

STATISTICS IN MEDICINE, 2012, 31 (04) :328-340

[13]

Kelsey P, 2003, BRIT J HAEMATOL, V122, P10

[14] INDICATIONS FOR PLATELET TRANSFUSION IN CHILDREN WITH ACUTE-LEUKEMIA [J].

MURPHY, S ;

LITWIN, S ;

HERRING, LM ;

KOCH, P ;

REMISCHOVSKY, J ;

DONALDSON, MH ;

EVANS, AE ;

GARDNER, FH .

AMERICAN JOURNAL OF HEMATOLOGY, 1982, 12 (04) :347-356

[15] The threshold for prophylactic platelet transfusions in adults with acute myeloid leukemia [J].

Rebulla, P ;

Finazzi, G ;

Marangoni, F ;

Avvisati, G ;

Gugliotta, L ;

Tognoni, G ;

Barbui, T ;

Mandelli, F ;

Sirchia, G .

NEW ENGLAND JOURNAL OF MEDICINE, 1997, 337 (26) :1870-1875

[16] Platelet transfusion for patients with cancer: Clinical practice guidelines of the American Society of Clinical Oncology [J].

Schiffer, CA ;

Anderson, KC ;

Bennett, CL ;

Bernstein, S ;

Elting, LS ;

Goldsmith, M ;

Goldstein, M ;

Hume, H ;

McCullough, JJ ;

McIntyre, RE ;

Powell, BL ;

Rainey, JM ;

Rowley, SD ;

Rebulla, P ;

Troner, MB ;

Wagnon, AH .

JOURNAL OF CLINICAL ONCOLOGY, 2001, 19 (05) :1519-1538

[17] Dose of Prophylactic Platelet Transfusions and Prevention of Hemorrhage [J].

Slichter, Sherrill J. ;

Kaufman, Richard M. ;

Assmann, Susan F. ;

McCullough, Jeffrey ;

Triulzi, Darrell J. ;

Strauss, Ronald G. ;

Gernsheimer, Terry B. ;

Ness, Paul M. ;

Brecher, Mark E. ;

Josephson, Cassandra D. ;

Konkle, Barbara A. ;

Woodson, Robert D. ;

Ortel, Thomas L. ;

Hillyer, Christopher D. ;

Skerrett, Donna L. ;

McCrae, Keith R. ;

Sloan, Steven R. ;

Uhl, Lynne ;

George, James N. ;

Aquino, Victor M. ;

Manno, Catherine S. ;

McFarland, Janice G. ;

Hess, John R. ;

Leissinger, Cindy ;

Granger, Suzanne ;

Exum, V. ;

Hendrix, D. ;

Ruys, N. ;

Werndli, J. ;

Koenig, K. ;

Turman, N. ;

Stublaski, J. ;

Lankiewicz, M. ;

Miller-Metcalfe, D. ;

Graminske, S. ;

Dora, R. ;

Heldke, S. ;

Divgi, A. B. ;

Boos, J. ;

Beekman, S. ;

Punzalan, R. ;

Neufeld, E. J. ;

Kang, T. ;

Hedstrom, J. ;

Harney, K. ;

Malynn, B. ;

Kelly, M. ;

Rowe, B. ;

Wallace, K. ;

Slate, S. .

NEW ENGLAND JOURNAL OF MEDICINE, 2010, 362 (07) :600-613

[18]

Slichter Sherrill J, 2007, Hematology Am Soc Hematol Educ Program, P172, DOI 10.1182/asheducation-2007.1.172

[19]

SOLOMON J, 1978, LANCET, V1, P267

[20] Do All Patients With Hematologic Malignancies and Severe Thrombocytopenia Need Prophylactic Platelet Transfusions?: Background, Rationale, and Design of a Clinical Trial (Trial of Platelet Prophylaxis) to Assess the Effectiveness of Prophylactic Platelet Transfusions [J].

Stanworth, Simon J. ;

Dyer, Claire ;

Choo, Louise ;

Bakrania, Lekha ;

Copplestone, Adrian ;

Llewelyn, Charlotte ;

Norfolk, Derek ;

Powter, Gillian ;

Littlewood, Tim ;

Wood, Erica M. ;

Murphy, Mike F. .

TRANSFUSION MEDICINE REVIEWS, 2010, 24 (03) :163-171

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