BACKGROUND:Prophylactic platelet (PLT) transfusions are standard treatment for patients receiving high-dose chemotherapy, but the optimal dose is not known. A randomized controlled trial was undertaken to examine the effectiveness of low-dose PLT transfusions and to determine the need for further studies. STUDY DESIGN AND METHODS: Patients (n = 111) with acute leukemia or undergoing autologous peripheral blood progenitor cell (PBPC) transplantation were randomly assigned to receive low-dose (3 PLT units) or standard-dose (5 PLT units) prophylactic PLT transfusions and were monitored daily for bleeding. Using a sequential Bayesian design, the difference in major bleeding events was determined. RESULTS: The percentage of patients with major bleeding events was 10.7 percent (95% credible region, 5.1%-21.2%) in the low-dose PLT group and 7.3 percent (95% credible region, 2.9%-17.2%) in the standard-dose PLT group. The two additional events in the low-dose group occurred when the PLT count exceeded 100 x 10(9) per L. There is an 89 percent probability that the absolute increase in major bleeds is less than 10 percent with low-dose PLT transfusions. The number of minor bleeding events was higher in the standard-dose group. Patients receiving low-dose PLT transfusions received 25 percent fewer PLT units. There was an 89 percent probability that low-dose transfusions reduced PLT utilization in patients with acute leukemia and a 60 percent probability in patients undergoing PBPC transplantation. CONCLUSION:Low-dose PLT transfusions appear to be safe and effective and reduce PLT utilization. They should be further evaluated in clinical trials designed to evaluate equivalency.
RCT Entities:
BACKGROUND: Prophylactic platelet (PLT) transfusions are standard treatment for patients receiving high-dose chemotherapy, but the optimal dose is not known. A randomized controlled trial was undertaken to examine the effectiveness of low-dose PLT transfusions and to determine the need for further studies. STUDY DESIGN AND METHODS: Patients (n = 111) with acute leukemia or undergoing autologous peripheral blood progenitor cell (PBPC) transplantation were randomly assigned to receive low-dose (3 PLT units) or standard-dose (5 PLT units) prophylactic PLT transfusions and were monitored daily for bleeding. Using a sequential Bayesian design, the difference in major bleeding events was determined. RESULTS: The percentage of patients with major bleeding events was 10.7 percent (95% credible region, 5.1%-21.2%) in the low-dose PLT group and 7.3 percent (95% credible region, 2.9%-17.2%) in the standard-dose PLT group. The two additional events in the low-dose group occurred when the PLT count exceeded 100 x 10(9) per L. There is an 89 percent probability that the absolute increase in major bleeds is less than 10 percent with low-dose PLT transfusions. The number of minor bleeding events was higher in the standard-dose group. Patients receiving low-dose PLT transfusions received 25 percent fewer PLT units. There was an 89 percent probability that low-dose transfusions reduced PLT utilization in patients with acute leukemia and a 60 percent probability in patients undergoing PBPC transplantation. CONCLUSION: Low-dose PLT transfusions appear to be safe and effective and reduce PLT utilization. They should be further evaluated in clinical trials designed to evaluate equivalency.
Authors: Sherrill J Slichter; Richard M Kaufman; Susan F Assmann; Jeffrey McCullough; Darrell J Triulzi; Ronald G Strauss; Terry B Gernsheimer; Paul M Ness; Mark E Brecher; Cassandra D Josephson; Barbara A Konkle; Robert D Woodson; Thomas L Ortel; Christopher D Hillyer; Donna L Skerrett; Keith R McCrae; Steven R Sloan; Lynne Uhl; James N George; Victor M Aquino; Catherine S Manno; Janice G McFarland; John R Hess; Cindy Leissinger; Suzanne Granger Journal: N Engl J Med Date: 2010-02-18 Impact factor: 91.245
Authors: Jason Tay; David Allan; Sara Beattie; Christopher Bredeson; Dean Fergusson; Dawn Maze; Mitchell Sabloff; Kednapa Thavorn; Alan Tinmouth Journal: BMJ Open Date: 2016-10-24 Impact factor: 2.692