title: Diaspirin-crosslinked hemoglobin reduces blood transfusion in noncardiac surgery: a multicenter, randomized, controlled, double-blinded trial.
abstract: In this randomized, prospective, double-blinded clinical trial, we sought to investigate whether diaspirin-crosslinked hemoglobin (DCLHb) can reduce the perioperative use of allogeneic blood transfusion. One-hundred-eighty-one elective surgical patients were enrolled at 19 clinical sites from 1996 to 1998. Selection criteria included anticipated transfusion of 2-4 blood units, aortic repair, and major joint or abdomino-pelvic surgery. Once a decision to transfuse had been made, patients received initially up to 3 250-mL infusions of 10% DCLHb (n = 92) or 3 U of packed red blood cells (PRBCs) (n = 89). DCLHb was infused during a 36-h perioperative window. On the day of surgery, 58 of 92 (64%; confidence interval [CI], 54%-74%) DCLHb-treated patients received no allogeneic PRBC transfusions. On Day 1, this number was 44 of 92 (48%; CI, 37%-58%) and decreased further until Day 7, when it was 21 of 92 (23%; CI, 15%-33%). During the 7-day period, 2 (1-4) units of PRBC per patient were used in the DCLHb group compared with 3 (2-4) units in the control patients (P = 0.002; medians and 25th and 75th percentiles). Mortality (4% and 3%, respectively) and incidence of suffering at least one serious adverse event (21% and 15%, respectively) were similar in DCLHb and PRBC groups. The incidence of jaundice, urinary side effects, and pancreatitis were more frequent in DCLHb patients. The study was terminated early because of safety concerns. Whereas the side-effect profile of modified hemoglobin solutions needs to be improved, our data show that hemoglobin solutions can be effective at reducing exposure to allogeneic blood for elective surgery.
  
  
  CONCLUSIONS
  In a randomized, double-blinded red blood cell controlled, multicenter trial, diaspirin-crosslinked hemoglobin spared allogeneic transfusion in 23% of patients undergoing elective noncardiac surgery. The observed side-effect profile indicates a need for improvement in hemoglobin development.
authors.affiliation: Departments of *General Anesthesiology, †Department of Orthopedic Surgery, ‡Department of Urology, §Department of Biostatistics & Epidemiology, The Cleveland Clinic Foundation; ∥Cleveland Clinic Foundation Health Science Center of the Ohio State University; ¶Department of Pathology, Ohio State University, Cleveland; #Department of Medicine, University of Wisconsin, Madison; **Division of Vascular Surgery, University of Arkansas for Medical Sciences, Little Rock; ††Baxter Hemoglobin Therapeutics, Boulder, Colorado; ‡‡Pfizer Global Research and Development, New York City; and §§Richard Prielipp, MD, Bowman Gray School of Medicine; Gerald Fulda, MD, Christiana Health Care Services; Irwin Gratz, DO, Cooper Hospital/UMC; Michael Salem, MD, George Washington University Medical Center; Ronald Kline, MD, Harper Hospital; Benjamin Guslits, MD, Henry Ford Hospital; Michael Pasquale, MD, Lehigh Valley Hospital; Lauraine Stewart, MD, McGuire VA Medical Center; Larry Hollier, MD, Mt. Sinai Medical Center; Bhatar Desai, MD, St. Anthony Hospital; Marc J. Shapiro, MD, St. Louis University Hospital; Ronald Pearl, MD, Stanford University Medical Center; Michael J. Williams, MD, Thomas Jefferson University; Dennis Doblar, PhD, MD, University of Alabama-Birmingham; Marc Hudson, MD, University of Pittsburgh Medical Center; Michael P. Eaton, MD, University of Rochester Medical Center; Lewis Gottschalk, MB, University of Texas-Houston Health Sciences Center; Mali Mathru, MD, University of Texas Medical Branch; Daniel Herr, MD, Washington Hospital Center.
authors.forename: Armin
authors.initials: A
authors.lastname: Schubert
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Przybelski
authors.forename: John F
authors.initials: JF
authors.lastname: Eidt
authors.forename: Larry C
authors.initials: LC
authors.lastname: Lasky
authors.forename: Kenneth E
authors.initials: KE
authors.lastname: Marks
authors.forename: Matthew
authors.initials: M
authors.lastname: Karafa
authors.forename: Andrew C
authors.initials: AC
authors.lastname: Novick
authors.forename: Jerome F
authors.initials: JF
authors.lastname: O'Hara
authors.forename: Michael E
authors.initials: ME
authors.lastname: Saunders
authors.forename: John W
authors.initials: JW
authors.lastname: Blue
authors.forename: John E
authors.initials: JE
authors.lastname: Tetzlaff
authors.forename: Edward
authors.initials: E
authors.lastname: Mascha
mesh_terms: D000368:Aged; D001241:Aspirin / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D001802:Blood Substitutes / Q000008:administration & dosage* / Q000009:adverse effects; D001803:Blood Transfusion; D004311:Double-Blind Method; D005260:Female; D006454:Hemoglobins / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D019990:Perioperative Care; D011446:Prospective Studies
chemical_list: D001802:Blood Substitutes; D006454:Hemoglobins; C083478:diaspirin-cross-linked hemoglobin; D001241:Aspirin