 |
THE FIRST RANDOMIZED TRIAL OF
HUMAN POLYMERIZED HEMOGLOBIN AS A BLOOD SUBSTITUTE IN ACUTE TRAUMA
AND EMERGENT SURGERY
Steven A. Gould, MD, FACS,
Ernest E. Moore, MD, FACS, David B. Hoyt, MD, FACS, Jon M. Burch,
MD, FACS, James B. Haenel, RRT, Joan Garcia, RN, CCRC, Richard
DeWoskin, BS, and Gerald S. Moss, MD, FACS
University of Illinois, Chicago, IL (Gould, Moss); Northfield
Laboratories Inc., Evanston, IL (Gould, DeWoskin); Department
of Surgery, Denver Health Medical Center, University of Colorado,
Denver, CO (Moore, Burch); and Department of Surgery, University
of California San Diego Medical Center, San Diego, CA (Hoyt,
Garcia)
ABSTRACT
BACKGROUND: Human polymerized hemoglobin (PolyHeme, Northfield
Laboratories Inc., Evanston, IL) is a universally compatible,
disease-free, oxygen-carrying resuscitative fluid. This is the
first prospective, randomized trial to compare directly the therapeutic
benefit of PolyHeme with that of allogeneic red blood cells (RBCs)
in the treatment of acute blood loss.
STUDY DESIGN: Forty-four trauma patients (33 male, 11
female) aged 19-75 years with an average ISS of 21 ±
10 were randomized to receive
red cells (n=23) or up to 6 U (300 g) of PolyHeme (n=21) as their
initial blood replacement after trauma and during emergent operations.
RESULTS: There were no serious or unexpected adverse events
related to PolyHeme. The PolyHeme infusion of 4.4 ± 2.0
units (mean ± SD) resulted in a plasma [Hb] of 3.9 ± 1.3
g/dL, which accounted for 40% of the total circulating [Hb].
There was no difference in total [Hb] between the groups before
infusion (10.4 ± 2.3 g/dL control versus 9.4 ± 1.9
g/dl experimental). At end-infusion the experimental RBC [Hb]
fell to 5.8 ± 2.8 g/dL versus 10.6 ±
1.8 g/dL (p<0.05) in the control,
although the total [Hb] was not different between the groups
or from pre-infusion. The total number of allogeneic red cell
transfusions for the control and experimental groups was 10.4
± 4.2
units versus 6.8 ± 3.9 units (p<0.05) through day 1, and
11.3 ± 4.1
units versus 7.8 ± 4.2 units (p=0.06) through day 3.
CONCLUSIONS: PolyHeme is safe in acute blood loss, maintains
total [Hb] in lieu of red cells despite the marked fall in RBC
[Hb], and reduces the use of allogeneic blood. PolyHeme appears
to be a clinically useful blood substitute.
____________________
Journal of the American College of Surgeons
August 1998, Volume 185 Number 14
JACS
menu
|
