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. 2018 Sep 10;8(9):e022690. doi: 10.1136/bmjopen-2018-022690

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© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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The design of a pharmacokinetic (PK) substudy is given here. In total, 28 patients who must give additional written informed consent will be examined regarding their apixaban levels before and after dialysis. Of these, apixaban levels will be assessed in 14 patients after the 3-day-long dialysis-free interval, and in another 14 patients after the short 2-day dialysis-free interval. Since patients on haemodialysis are regularly treated in two shifts (AM and PM), the 14 patients will be splitted again and apixaban levels will be assessed in 7 patients of the AM shift and another 7 patients of the PM shift. This might be of interest since patients will be instructed to take their apixaban between 07:00 to 08:00 AM and PM, independent from the start of their dialysis shifts, so plasma levels may vary between the groups.