title: The life-sustaining capacity of human polymerized hemoglobin when red cells might be unavailable.
abstract: BACKGROUND
  Human polymerized hemoglobin (PolyHeme, Northfield Laboratories, Evanston, IL) is a universally compatible, immediately available, disease-free, oxygen-carrying resuscitative fluid being developed as a red cell substitute for use in urgent blood loss. PolyHeme should be particularly useful when red cells may be temporarily unavailable. This article assesses survival at life-threatening RBC hemoglobin concentration ([Hb]) in massively bleeding patients who do not receive red cells.
  
  
  METHODS
  There were 171 patients who received rapid infusion of 1 to 20 units (1,000 g, 10 L) of PolyHeme in lieu of red cells as initial oxygen-carrying replacement in trauma and urgent surgery. The protocol simulated the unavailability of red cells, and the progressive fall in RBC [Hb] in bleeding patients was quantified. Thirty-day mortality was compared with a historical control group of 300 surgical patients who refused red cells on religious grounds.
  
  
  RESULTS
  A total of 171 patients received rapid infusion of 1 to 2 units (n = 45), 3 to 4 units (n = 45), 5 to 9 units (n = 47), or 10 to 20 units (n = 34) of PolyHeme. Forty patients had a nadir RBC [Hb] < or = 3 g/dL (mean, 1.5 +/- 0.7 g/dL). But total [Hb] was adequately maintained (mean, 6.8 +/- 1.2 g/dL) because of plasma [Hb] added by PolyHeme. The 30-day mortality was 25.0% (10/40 patients) compared with 64.5% (20/31 patients) in historical control patients at these RBC [Hb] levels.
  
  
  CONCLUSIONS
  PolyHeme increases survival at life-threatening RBC [Hb] by maintaining total [Hb] in the absence of red cell transfusion. PolyHeme should be useful in the early treatment of urgent blood loss and resolve the dilemma of unavailability of red cells.
authors.affiliation: Northfield Laboratories Inc., Evanston, IL, USA.
authors.forename: Steven A
authors.initials: SA
authors.lastname: Gould
authors.forename: Ernest E
authors.initials: EE
authors.lastname: Moore
authors.forename: David B
authors.initials: DB
authors.lastname: Hoyt
authors.forename: Paul M
authors.initials: PM
authors.lastname: Ness
authors.forename: Edward J
authors.initials: EJ
authors.lastname: Norris
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Carson
authors.forename: George A
authors.initials: GA
authors.lastname: Hides
authors.forename: Ian H G
authors.initials: IH
authors.lastname: Freeman
authors.forename: Richard
authors.initials: R
authors.lastname: DeWoskin
authors.forename: Gerald S
authors.initials: GS
authors.lastname: Moss
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001802:Blood Substitutes / Q000627:therapeutic use*; D004906:Erythrocyte Count; D017707:Erythrocyte Transfusion; D005260:Female; D006454:Hemoglobins / Q000032:analysis / Q000627:therapeutic use*; D006470:Hemorrhage / Q000097:blood / Q000401:mortality / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015996:Survival Rate
chemical_list: D001802:Blood Substitutes; D006454:Hemoglobins; C037158:polyhemoglobin