A randomized controlled trial comparing standard- and low-dose strategies for transfusion of platelets (SToP) to patients with thrombocytopenia.
A noninferiority study was performed comparing low-dose and standard-dose prophylactic platelet transfusions. A double-blind randomized controlled trial (RCT) was performed in 6 sites in 3 countries. Thrombocytopenic adults requiring prophylactic platelet transfusion were randomly allocated to standard-dose (300-600 x 10(9) platelets/product) or low-dose (150- < 300 x 10(9) platelets/product) platelets. The primary outcome (World Health Organization [WHO] bleeding > or = grade 2) was assessed daily through clinical examination, patient interview, and chart review. A WHO grade was assigned through adjudication. The Data Safety Monitoring Board stopped the study because the difference in the grade 4 bleeding reached the prespecified threshold of 5%. At this time, 129 patients had been randomized and 119 patients were included in the analysis (58 low dose; 61 standard dose). Three patients in the low-dose arm (5.2%) had grade 4 bleeds compared with none in the standard-dose arm. WHO bleeding grade 2 or higher was 49.2% (30/61) in the standard-dose arm and 51.7% (30/58) in the low-dose group (relative risk [RR], 1.052; 95% confidence interval [CI], 0.737-1.502). A higher rate of grade 4 bleeding in patients receiving low-dose prophylactic platelet transfusions resulted in this RCT being stopped. Whether this finding was due to chance or represents a real difference requires further investigation. These clinical studies are registered on (http://www.clinicaltrials.gov) as NCT00420914.
Heddle
Nancy M
NM
Department of Medicine, McMaster University, Hamilton, ON, Canada. heddlen@mcmaster.ca
Cook
Richard J
RJ
Tinmouth
Alan
A
Kouroukis
C Tom
CT
Hervig
Tor
T
Klapper
Ellen
E
Brandwein
Joseph M
JM
Szczepiorkowski
Zbigniew M
ZM
AuBuchon
James P
JP
Barty
Rebecca L
RL
Lee
Ker-Ai
KA
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced / Q000628:therapy; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D010976:Platelet Count; D017713:Platelet Transfusion / Q000379:methods*; D012720:Severity of Illness Index; D013921:Thrombocytopenia / Q000139:chemically induced / Q000628:therapy*; D014944:World Health Organization
D000970:Antineoplastic Agents