For Release: September 7, 2007
Contact: DMS Communications 603-650-1492
Drug to Boost Red Blood Cells May Benefit Critically Ill Trauma Patients
HANOVER, NH—Treatment with a blood stimulator significantly reduced death, particularly in trauma patients admitted to the intensive care unit, according to results of a Dartmouth-led national trial.
The study, published in the September 6 New England Journal of Medicine, helps clarify the use of recombinant human erythropoietin (epoetin alfa) to treat anemia in critically ill patients. Such patients often receive red blood cell transfusions to boost the blood supply, but the outcomes are poor.
Although the epoetin alfa therapy did not decrease the number of patients who needed a red blood cell transfusion, it lowered mortality in patients with trauma.
"The improvement in mortality findings is encouraging and this is a potentially important finding in this clinical setting," said, Dr. Howard Corwin, professor of anesthesiology and of medicine at Dartmouth Medical School and Dartmouth-Hitchcock Medical Center, who is first author of the study.
The prospective, multicenter, concealed study involved 1,460 medical, surgical, or trauma patients 18 years or older who were admitted to an ICU for two days or more with a low hemoglobin. They were randomly assigned to receive epoetin alfa (733 patients) or a placebo (727) ) via weekly injection for up to three weeks.
The primary endpoint was the percent of patients receiving any red cell transfusion (RBC) through day 29. Secondary endpoints were the units transfused through day 42, change in hemoglobin from baseline to day 29 and mortality at days 29 and 140. Analyses by the prospectively identified admission groups (trauma, surgery non-trauma and medical non-trauma) were performed similarly to the overall population.
There was no significant difference in the percentage of patients who received a RBC transfusion at day 29 between the two groups, nor was there any difference between treatment groups in the total number of RBC units transfused through study day 42. Despite the lack of transfusion reduction, the investigators observed a beneficial mortality pattern.
Mortality at study day 29 was significantly lower in the epoetin alfa group and was most apparent in the trauma subgroup (3.5% vs. 6.6%), and again at day 140 (6.% vs. 9.2%). Moreover, the hemoglobin increase was also greater in the treatment group. As expected, however, in a population of critically ill patients, adverse events were frequent, and there was a significant increase in thrombotic vascular complications associated with the therapy.
The results suggest that epoetin alfa can help trauma patients, the researchers noted. However, they urged caution and careful consideration of the risk-benefit ratio before administration.
Co authors were members of the EPO Critical Care Trials Group, including Dr. Andrew Gettinger of DMS. The study was sponsored by Johnson & Johnson Pharmaceutical Research & Development, LLC and used their drug, called PROCRIT.