title: A randomized controlled trial comparing standard- and low-dose strategies for transfusion of platelets (SToP) to patients with thrombocytopenia.
abstract: 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.
authors.affiliation: Department of Medicine, McMaster University, Hamilton, ON, Canada. heddlen@mcmaster.ca
authors.forename: Nancy M
authors.initials: NM
authors.lastname: Heddle
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Cook
authors.forename: Alan
authors.initials: A
authors.lastname: Tinmouth
authors.forename: C Tom
authors.initials: CT
authors.lastname: Kouroukis
authors.forename: Tor
authors.initials: T
authors.lastname: Hervig
authors.forename: Ellen
authors.initials: E
authors.lastname: Klapper
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Brandwein
authors.forename: Zbigniew M
authors.initials: ZM
authors.lastname: Szczepiorkowski
authors.forename: James P
authors.initials: JP
authors.lastname: AuBuchon
authors.forename: Rebecca L
authors.initials: RL
authors.lastname: Barty
authors.forename: Ker-Ai
authors.initials: KA
authors.lastname: Lee
mesh_terms: 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
chemical_list: D000970:Antineoplastic Agents