title: Red blood cell transfusion triggers in acute leukemia: a randomized pilot study.
abstract: Red blood cell (RBC) transfusion thresholds have yet to be examined in large randomized trials in hematologic malignancies. This pilot study in acute leukemia uses a restrictive compared to a liberal transfusion strategy.
  
  
  
  A randomized (2:1) study was conducted of restrictive (LOW) hemoglobin (Hb) trigger (7 g/dL) compared to higher (HIGH) Hb trigger (8 g/dL). The primary outcome was feasibility of conducting a larger trial. The four requirements for success required that more than 50% of the eligible patients could be consented, more than 75% of the patients randomized to the LOW arm tolerated the transfusion trigger, fewer than 15% of patients crossed over from the LOW arm to the HIGH arm, and no indication for the need to pause the study for safety concerns. Secondary outcomes included fatigue, bleeding, and RBCs and platelets transfused.
  
  
  
  Ninety patients were consented and randomly assigned to LOW to HIGH. The four criteria for the primary objective of feasibility were met. When the number of units transfused was compared, adjusting for baseline Hb, the LOW arm was transfused on average 8.0 (95% confidence interval [CI], 6.9-9.1) units/patient while the HIGH arm received 11.7 (95% CI, 10.1-13.2) units (p = 0.0003). There was no significant difference in bleeding events or neutropenic fevers between study arms.
  
  
  
  This study establishes feasibility for trial of Hb thresholds in leukemia through demonstration of success in all primary outcome metrics and a favorable safety profile. This population requires further study to evaluate the equivalence of liberal and restrictive transfusion thresholds in this unique clinical setting.
authors.affiliation: The Sidney Kimmel Cancer Center at Johns Hopkins, The Johns Hopkins School of Medicine, Baltimore, Maryland.
authors.forename: Amy E
authors.initials: AE
authors.lastname: DeZern
authors.affiliation: The Sidney Kimmel Cancer Center at Johns Hopkins, The Johns Hopkins School of Medicine, Baltimore, Maryland.
authors.forename: Katherine
authors.initials: K
authors.lastname: Williams
authors.affiliation: The Sidney Kimmel Cancer Center at Johns Hopkins, The Johns Hopkins School of Medicine, Baltimore, Maryland.
authors.forename: Marianna
authors.initials: M
authors.lastname: Zahurak
authors.affiliation: The Sidney Kimmel Cancer Center at Johns Hopkins, The Johns Hopkins School of Medicine, Baltimore, Maryland.
authors.forename: Wesley
authors.initials: W
authors.lastname: Hand
authors.affiliation: The Sidney Kimmel Cancer Center at Johns Hopkins, The Johns Hopkins School of Medicine, Baltimore, Maryland.|Division of Pulmonary and Critical Care Medicine, Department of Medicine, The Johns Hopkins School of Medicine, Baltimore, Maryland.
authors.forename: R Scott
authors.initials: RS
authors.lastname: Stephens
authors.affiliation: The Sidney Kimmel Cancer Center at Johns Hopkins, The Johns Hopkins School of Medicine, Baltimore, Maryland.|Division of Transfusion Medicine, Department of Pathology, The Johns Hopkins School of Medicine, Baltimore, Maryland.
authors.forename: Karen E
authors.initials: KE
authors.lastname: King
authors.affiliation: Department of Anesthesiology and Critical Care Medicine, The Johns Hopkins School of Medicine, Baltimore, Maryland.
authors.forename: Steven M
authors.initials: SM
authors.lastname: Frank
authors.affiliation: Division of Transfusion Medicine, Department of Pathology, The Johns Hopkins School of Medicine, Baltimore, Maryland.
authors.forename: Paul M
authors.initials: PM
authors.lastname: Ness
mesh_terms: D000208:Acute Disease; D000368:Aged; D017707:Erythrocyte Transfusion; D005260:Female; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D007938:Leukemia / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D017410:Practice Guidelines as Topic / Q000592:standards
chemical_list: D006454:Hemoglobins