Table 1 Criteria for the evaluation of clinical efficacy of clotting prevention as evaluated visually by the investigator at the study site at the end of the hemodialysis after the first session and after week 8
Score | Lines and bubble catcher | Dialyser | |
|---|---|---|---|
Satisfactory | 0 | No clots | Good, clear dialyser |
1 | Minimal clots | Light redness overall or only a few (< 3) and small (< 2 mm) dark red fibre bundles | |
Unstatisfactory | 2 | Moderate clotting | Moderate redness overall or several (≥ 3) small or few large (≥ 2 mm) dark red fibre bundles |
3 | Severe clotting | Total clotting of the dialyser (stop in hemodialysis, requiring change of the extracorporeal circuit). | |