A Medical Device Daily

Northfield Laboratories (Evanston, Illinois) said patient enrollment is complete in its pivotal Phase III trauma study with PolyHeme, the company's human hemoglobin-based oxygen-carrying red blood cell substitute.

Steven Gould, MD, CEO and chairman, said, "We are eager to begin the data analysis, and look forward to reporting top-line results from the study in the fall."

The PolyHeme trial is the first study in the U.S. designed to evaluate the safety and efficacy of an oxygen-carrying red blood cell substitute beginning at the scene of injury and continuing during transport and in the early hospital period.

The study had a planned enrollment of 720 and was conducted at major Level I trauma centers throughout the U.S. The primary endpoint is survival at 30 days.

PolyHeme is being developed as a red blood cell substitute for the treatment of life-threatening blood loss, when an oxygen-carrying fluid is required and red blood cells are not available. The product is a solution of chemically modified human hemoglobin that requires no cross-matching and is therefore compatible with all blood types. It has a shelf life of more than 12 months.