Institute of Biomaterial Science and Berlin-Brandenburg Centre for Regenerative Therapies (BCRT), Helmholtz-Zentrum Geesthacht, Teltow, Germany.
Max Bergmann Center of Biomaterials Dresden, Leibniz Institute of Polymer Research Dresden, Dresden, Germany.
Colloids Surf B Biointerfaces. 2017 Oct 1;158:416-422. doi: 10.1016/j.colsurfb.2017.06.053. Epub 2017 Jul 3.
The regulatory agencies provide recommendations rather than protocols or standard operation procedures for the hemocompatibility evaluation of novel materials e.g. for cardiovascular applications. Thus, there is a lack of specifications with regard to test setups and procedures. As a consequence, laboratories worldwide perform in vitro assays under substantially different test conditions, so that inter-laboratory and inter-study comparisons are impossible. Here, we report about a prospective, randomized and double-blind multicenter trial which demonstrates that standardization of in vitro test protocols allows a reproducible assessment of platelet adhesion and activation from fresh human platelet rich plasma as possible indicators of the thrombogenicity of cardiovascular implants. Standardization of the reported static in vitro setup resulted in a laboratory independent scoring of the following materials: poly(dimethyl siloxane) (PDMS), poly(ethylene terephthalate) (PET) and poly(tetrafluoro ethylene) (PTFE). The results of this in vitro study provide evidence that inter-laboratory and inter-study comparisons can be achieved for the evaluation of the adhesion and activation of platelets on blood-contacting biomaterials by stringent standardization of test protocols.
监管机构为新型材料（例如心血管应用）的血液相容性评估提供建议，而不是协议或标准操作程序。因此，在测试设置和程序方面缺乏规范。结果，世界各地的实验室在实质上不同的测试条件下进行体外检测，因此实验室之间和研究之间的比较是不可能的。在这里，我们报告了一项前瞻性、随机和双盲多中心试验，该试验表明，体外测试方案的标准化允许从新鲜的富含血小板的人血浆中可重复地评估血小板黏附和激活，作为心血管植入物血栓形成性的可能指标。报告的静态体外设置的标准化导致以下材料的独立于实验室的评分：聚二甲基硅氧烷（PDMS）、聚对苯二甲酸乙二醇酯（PET）和聚四氟乙烯（PTFE）。这项体外研究的结果提供了证据，即通过严格的测试方案标准化，可以实现对血液接触生物材料上血小板黏附和激活的实验室间和研究间比较。
