A scoping review protocol on active drug monitoring of direct oral anticoagulants on vulnerable patient groups to detect potential adverse risks

Abstract

Background

Emerging data show an increased risk of adverse effects (thrombotic or bleeding events) in patients using the direct oral anticoagulants (DOAC) rivaroxaban, apixaban, edoxaban and dabigatran. Although DOAC are prescribed with a fixed-dose and generally do not require routine drug-level monitoring, certain clinical circumstances may require drug-level monitoring to prevent or manage adverse drug effects. Currently, there is limited evidence whether drug-level monitoring is beneficial for specific patient population or clinical circumstances, and the lack of a specific therapeutic window is a huge knowledge gap in clinical practice.

Methods

A systematic search of the electronic database Pubmed (including MEDLINE) will be conducted to identify studies on active drug monitoring of DOAC to detect potential adverse events such as bleeding or thrombotic complications. At least two investigators will independently perform a two-stage study selection of the identified studies. The first stage will consist of title and abstract screening while the second stage will consist of a full-text review followed by data extraction. Once completed, a thematic analysis will be conducted to evaluate whether drug-monitoring is beneficial for specific clinical circumstances or at risk patient populations and initial inventory of clinical guidance opportunities by applying target concentrations in DOAC monitoring.

Conclusion

We anticipate that this review will summarize available data on monitoring of DOACs used in clinical practice and provide evidence of patients at risk of adverse effects. When available, the application of specific target concentrations for guidance of DOAC treatment for the identified patient populations will be summarized. Addressing this knowledge gap will help guide the development of future clinical trials on monitoring strategies for high risk patients using DOAC.