Abstract: BACKGROUND: As a medical device that is in contact with circulating blood in a large area for a long time, blood compatibility testing of the blood perfusion device is very important. 
OBJECTIVE: To test the blood compatibility of the test blood perfusion device.
METHODS: The resin microparticles in the test blood perfusion device and the marketed blood perfusion device (as a control) were mixed with human anticoagulated blood respectively, and placed on a 37 °C rotating incubator for hematology, platelet, coagulation and complement detection in vitro. The two kinds of resin microparticles were respectively contacted with rabbit semi-anticoagulated blood, and the degree of thrombosis was compared by detecting the remaining fibrinogen content in the plasma. The two resin microparticles were placed in physiological saline, and then diluted anticoagulated rabbit blood was added for hemolysis experiment. The animal experiment was approved by the Ethics Committee of National Institutes for Food and Drug Control.
RESULTS AND CONCLUSION: (1) The activated partial thromboplastin time and platelet concentration of the test blood perfusion device resin particle group were greater than those of the control perfusion device resin particle group (P < 0.01), and the total complement activity was lower than that of the control perfusion device resin particle group (P < 0.01). There was no statistically significant difference in prothrombin time, fibrinogen, the number of leukocytes and erythrocytes between the two groups (P > 0.05). (2) In the thrombosis test, there was no statistical difference in the concentration of fibrinogen between the two groups (P > 0.05). (3) The hemolysis rate of the resin microparticles in the test blood perfusion device was 0.2%. (4) The results showed that compared with the resin microparticles in the control perfusion device, the resin microparticles in the test blood perfusion device activated the complement and the coagulation system more severely (relative percentage to the control between 85%-115%), but the effect on the number of platelets is relatively small; the hemolysis rate of the resin particles in the test blood perfusion device is low; and its blood compatibility is acceptable.

Key words: material, blood, perfusion device, coagulation, complement, platelet, hematology, thrombosis, hemolysis