Abstract
The criteria for demonstrating the efficacy of red cell substitutes has been a problem from the beginning of research on these materials. This problem derives, in large part, from the fact that red cells, per se, have never been subjected to a controlled clinical trial for the purpose of demonstrating their efficacy. There is, therefore, no standard to compare red cell substitutes. The paucity of fundamental research in the area of oxygen transport does not support the use of laboratory assays as definitive endpoints. The problem of demonstrating efficacy is on the minds of investigators from the outset. It is a special problem with red cell substitutes because the criteria for transfusing red cells constitute a subject that itself is mired in controversy.
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