Preliminary Data on Blood Substitute Grim

The Evanston, Ill., company hoping to be the first to market a blood substitute said 46 patients in a study died after being given the substitute.

Northfield Laboratories said preliminary data contained "discrepancies" in the study of trauma patients, of which 35 died under standard treatment, compared to 46 among patients receiving the substitute PolyHeme, the Wall Street Journal said Wednesday.

Northfield Chief Executive Steven Gould said the death rate findings weren't statistically significant and the company plans to "move forward toward submission" of the data to the U.S. Food and Drug Administration.

The study was designed to evaluate whether the blood substitute was superior to, or not worse than, standard therapy. Badly hemorrhaging trauma patients were assigned randomly to PolyHeme, or to the standard therapy of saline solution in the ambulance and donor blood in the hospital. A total of 722 patients were studied, with 349 patients receiving the blood substitute and 363 getting standard treatment.

William Hoffman, cardiac surgery critical care chief at Massachusetts General Hospital and former medical director of another blood substitute company, said it would be irresponsible for the FDA to grant approval for PolyHeme based on the preliminary data.

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