title: A no-prophylaxis platelet-transfusion strategy for hematologic cancers.
abstract: 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 10×10(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.).
authors: National Health Service (NHS) Blood and Transplant, Oxford University Hospitals NHS Trust, John Radcliffe Hospital, and Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.
authors: Simon J
authors: SJ
authors: Stanworth
authors: Lise J
authors: LJ
authors: Estcourt
authors: Gillian
authors: G
authors: Powter
authors: Brennan C
authors: BC
authors: Kahan
authors: Claire
authors: C
authors: Dyer
authors: Louise
authors: L
authors: Choo
authors: Lekha
authors: L
authors: Bakrania
authors: Charlotte
authors: C
authors: Llewelyn
authors: Timothy
authors: T
authors: Littlewood
authors: Richard
authors: R
authors: Soutar
authors: Derek
authors: D
authors: Norfolk
authors: Adrian
authors: A
authors: Copplestone
authors: Neil
authors: N
authors: Smith
authors: Paul
authors: P
authors: Kerr
authors: Gail
authors: G
authors: Jones
authors: Kavita
authors: K
authors: Raj
authors: David A
authors: DA
authors: Westerman
authors: Jeffrey
authors: J
authors: Szer
authors: Nicholas
authors: N
authors: Jackson
authors: Peter G
authors: PG
authors: Bardy
authors: Dianne
authors: D
authors: Plews
authors: Simon
authors: S
authors: Lyons
authors: Linley
authors: L
authors: Bielby
authors: Erica M
authors: EM
authors: Wood
authors: Michael F
authors: MF
authors: Murphy
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use; D005260:Female; D019337:Hematologic Neoplasms / Q000150:complications / Q000628:therapy*; D006470:Hemorrhage / Q000517:prevention & control*; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D010976:Platelet Count; D017713:Platelet Transfusion; D033581:Stem Cell Transplantation; D013921:Thrombocytopenia / Q000209:etiology / Q000628:therapy*
chemical_list: D000970:Antineoplastic Agents