PolyHeme

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Template:NeutralityPolyHeme is a human hemoglobin-based temporary oxygen-carrying red blood cell substitute in development for the treatment of urgent, large volume blood loss in trauma and resultant surgical settings, with a particular focus on settings where blood is not immediately available.

PolyHeme® is a solution of chemically modified human hemoglobin which simultaneously restores lost blood volume and hemoglobin levels and is designed for rapid, massive infusion.

PolyHeme’s characteristics include:

Simultaneously restoring lost blood volume and hemoglobin levels.
Universal compatibility with all human blood types (does not require typing or cross-matching before infusion).
Immediately available.
Has not caused transfusion reactions in any testing to date.
Has extended shelf life of over 12 months.
Is manufactured from human red blood cells using steps to reduce the risk of viral transmission.

Polyheme is produced by Northfield Laboratories Inc. and is currently in a Phase III trial. The company currently uses expired human blood from which the hemoglobin is extracted and purified. It is thought to be totally non-toxic due to a series of chemical treatments to make it compatible with all blood types and avoid problems associated with earlier experiments using artificial blood, such as liver and kidney failure.

PolyHeme can be stored at room temperature, versus donated whole blood which requires refrigeration. This makes PolyHeme advantageous in emergency situations. It does not have most attributes of whole blood, such as the ability to coagulate.

The testing which is currently underway in 31 (as of February 15, 2006) Level I trauma centers around the country under a Food and Drug Administration special category (21CFR 50.24) in 1996 that allows its use without patient consent in special circumstances. PolyHeme is the 15^th such experiment allowed by the FDA.

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