Product Description
Potential Uses
How PolyHeme® Is Made
Clinical Trial Experience
Non-Randomized
Trauma Trial
PolyHeme® Pivotal
Phase III Trial
Potential Battlefield Use
Development History
Selected Bibliography

 

Non-Randomized Trauma Trial in Hospital Setting


Results of this trial were presented in part at the Clinical Congress of the American College of Surgeons, Chicago, IL, in October 2001, and were subsequently published in the October 2002 issue of the Journal of the American College of Surgery.

In this study, 171 patients in the hospital setting received rapid infusion of 1 to 20 units (1,000 g, 10 L) of PolyHeme® in lieu of red cells as initial oxygen-carrying replacement in trauma and urgent surgery. Some of these patients were kept alive while losing virtually all of their blood during ongoing bleeding and receiving only PolyHeme® as replacement. Observations in these patients have suggested the life-sustaining potential of PolyHeme® in the treatment of urgent life-threatening blood loss and life-threatening hemoglobin levels.

Gould S, Moore EE, Hoyt DB, et al., The Life-Sustaining Capacity of Human Polymerized Hemoglobin when Red Cells Might Be Unavailable. J Am College Surg 2002;195:445-455.

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