Friday, 17 May 2013

TOPPS study published last week in NEJM

new england

The TOPPS (trial of prophylactic platelet transfusions) study published last week in NEJM represents the outcome of several years of work by UK and Australian researchers.  A/Prof Erica Wood, Head of the Transfusion Research Unit, was the Chief Investigator for Australia.

Platelet transfusions are given therapeutically (to control bleeding) or prophylactically (to prevent bleeding) to patients with low platelet counts. Most platelet transfusions are administered as prophylaxis to patients with haematologic malignancies (because of disease or its treatment, such as chemotherapy, the bone marrow is not producing sufficient platelets).

Several studies have examined the appropriate threshold (patient platelet count) at which to administer such transfusions, but the basic premise (whether prophylactic platelet transfusions actually prevent bleeding) has not been examined until very recently. TOPPS assessed whether a no-prophylaxis platelet transfusion strategy was as effective and safe as giving prophylaxis. This question is important, because prophylaxis is currently the standard of care. However, transfusions carry risks and costs, and if they are not necessary (because prophylaxis does not prevent bleeding) this would have important implications.

TOPPS was a randomised, parallel-group, open-label, non-inferiority trial at 14 UK and Australian centres. Six hundred adults with haematologic malignancies or undergoing autologous or allogeneic stem cell transplantation (SCT) were randomised to receive (or not), prophylactic transfusions when morning platelet counts were <10x109/L.

Overall, WHO grade 2-4 bleeding (grade 4 being most serious) occurred in 50% patients in the no-prophylaxis group compared to 43% receiving prophylaxis. Patients in the no-prophylaxis group had more days with bleeding, and shorter time to first bleed. Patients with acute leukaemia or undergoing allogeneic SCT not receiving prophylaxis had significantly more bleeding events. Bleeding rates were lower, and not different between the two study arms, for autologous SCT patients. Platelet use was markedly reduced in the no-prophylaxis arm.

TOPPS concluded that while the vast majority of bleeding episodes were not serious, over 40% patients experienced WHO grade 2 or higher bleeds despite prophylaxis. The researchers noted that additional strategies are required to prevent bleeding in haematology patients, and these will be explored in future studies.

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