Evaluation of platelet adhesion and activation on polymers: Round-robin study to assess inter-center variability

Colloids Surf B Biointerfaces. 2017 Oct 1;158:416-422. doi: 10.1016/j.colsurfb.2017.06.053. Epub 2017 Jul 3.

Abstract

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.

Keywords: Biomaterial; Hemocompatibility; Multicenter trial; Polymer; Standardization; Thrombogenicity.

MeSH terms

  • Animals
  • Biocompatible Materials / chemistry
  • Biocompatible Materials / pharmacology
  • Blood Platelets / drug effects*
  • Double-Blind Method
  • Humans
  • Multicenter Studies as Topic
  • Platelet Activation / drug effects
  • Platelet Adhesiveness / drug effects
  • Polyethylene Terephthalates / chemistry
  • Polymers / chemistry
  • Polymers / pharmacology*
  • Prospective Studies

Substances

  • Biocompatible Materials
  • Polyethylene Terephthalates
  • Polymers