New Data Supports Safety of Blood Substitute
Biopure Corporation recently completed a Phase III trial of their new substitute product, HBOC-201. Findings from the trial were published in the Journal of Trauma: Injury, Infection, and Critical Care.
Almost 700 patients were recruited to participate, all were undergoing elective orthopaedic procedures and were at least 18 years of age. Patients randomly received either one blood unit or the equivalent amount (65 grams) of HBOC-21. Patient could receive a maximum of ten “units” over a six day time frame.
Patients were monitored on a daily basis and again at six weeks following the initial surgery. Findings indicate that, on average, patients who received HBOC-201 required fewer treatment units. Those patients generally required two units less than those patients who received blood transfusions.
Among patients with moderate transfusion needs, the mortality rate was equivalent in the two treatment groups. However, the rate was higher among the patients with higher transfusion requirements who received HBOC-201, 5 percent compared to 3 percent in the group that received blood.
Data indicates that the product, a hemoglobin-based oxygen carrier, was less effective in elderly patients, those who were over age 80 with more acute disease and had higher requirements for transfusions. The study documented at least 21 adverse events, either central nervous or cardiac events. Those were considered secondary to underlying disease or other factors, rather than the blood product itself.
June 16, 2008 Related topics: Critical Care, Laboratory, New Technology & Innovation, Quality, Safety, Errors, Surgery