An in vitro test system for estimation of blood compatibility of biomaterials

Abstract

An in vilro test cell is described which permits exposure of artificial surface5 in sheet or film form to native human blood in the absence of a blood-air interface. Evaluation of Cuprophane, polyethylene, Silastic, and silicone-coated glass in the in vitro cell showed Cuprophane and silicone-coated glass to produce the least activation of the intrinsic coagulation system, while Silastic produced the greatest degree of activation. Polyethylene gave results intermediate between those obtained with the other materials. Each of these four different materials wm evaluated in the elliptical cell test system multiple times with blood from 13 different donors.Our data suggest that with the present test system and the proper experimental design, one might expect that, "on the average," performance of 36 tests on each of two materials will be sufficient for a 10% difference in their compatibility with blood to be statistically significant at the 5% level. The number of tests is 26 for significance at the 10% level.