Low-dose prophylactic platelet transfusions in recipients of an autologous peripheral blood progenitor cell transplant and patients with acute leukemia: a randomized controlled trial with a sequential Bayesian design

Transfusion. 2004 Dec;44(12):1711-9. doi: 10.1111/j.0041-1132.2004.04118.x.

Abstract

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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Disease
  • Adult
  • Aged
  • Aged, 80 and over
  • Bayes Theorem
  • Female
  • Hemorrhage / epidemiology
  • Humans
  • Leukemia / blood
  • Leukemia / therapy*
  • Male
  • Middle Aged
  • Peripheral Blood Stem Cell Transplantation*
  • Platelet Count
  • Platelet Transfusion*
  • Research Design
  • Transplantation, Autologous