Stanworth S.J.,University of Oxford |
Estcourt L.J.,University of Oxford |
Powter G.,University of Oxford |
Powter G.,MRC Clinical Studies Unit |
And 25 more authors.
New England Journal of Medicine | Year: 2013
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 10×109 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.) Copyright © 2013 Massachusetts Medical Society. Source
Grant S.W.,University of Manchester |
Grayson A.D.,Liverpool Heart and Chest Hospital NHS Foundation Trust |
Zacharias J.,Lancashire Cardiac Center |
Dalrymple-Hay M.J.R.,Plymouth Derriford Hospital |
And 2 more authors.
Heart | Year: 2012
Objective: Endoscopic vein harvesting (EVH) is increasingly used as an alternative to open vein harvesting (OVH) for coronary artery bypass graft (CABG) surgery. Concerns about the safety of EVH with regard to midterm clinical outcomes following CABG have been raised. The objective of this study was to assess the impact of EVH on short-term and midterm clinical outcomes following CABG. Design: This was a retrospective analysis of prospectively collected multi-centre data. A propensity score was developed for EVH and used to match patients who underwent EVH to those who underwent OVH. Setting: Blackpool Victoria Hospital, Plymouth Derriford Hospital and the University Hospital of South Manchester were the main study settings. Patients: There were 4709 consecutive patients who underwent isolated CABG using EVH or OVH between January 2008 and July 2010. Main outcome measures: The main outcome measure was a combined end point of death, repeat revascularisation or myocardial infarction. Secondary outcome measures included in-hospital morbidity, in-hospital mortality and midterm mortality. Results Compared to OVH, EVH was not associated with an increased risk of the main outcome measure at a median follow-up of 22 months (HR 1.15; 95% CI 0.76 to 1.74). EVH was also not associated with an increased risk of in-hospital morbidity, in-hospital mortality (0.9% vs 1.1%, p=0.71) or midterm mortality (HR 1.04; 95% CI 0.65 to 1.66). Conclusions: This multi-centre study demonstrates that at a median follow-up of 22 months, EVH was not associated with adverse short-term or midterm clinical outcomes. However, before the safety of EVH can be clearly determined, further analyses of long-term clinical outcomes are required. Source