Algorithm for Rapid Exclusion of Clinically Relevant Plasma Levels of Direct Oral Anticoagulants in Patients Using the DOAC Dipstick: An Expert Consensus Paper
Job Harenberg, Robert C. Gosselin, Adam Cuker, Cecilia Becattini, Ingrid Pabinger, Sven Poli, Jeffrey I. Weitz, Walter Ageno, Rupert Bauersachs, Ivana Ćelap, Philip Choi, James D. Douketis, Jonathan Douxfils, Ismaı̈l Elalamy, Anna Falanga, Jawed Fareed, Emmanuel J. Favaloro, Grigoris Gerotziafas, Harald Herkner, Svetlana Hetjens, Lars Heubner, Robert Klamroth, F. Langer, Gregory Y.H. Lip, Brian Mac Grory, Sandra Margetić, Anne Merrelaar, Marika Pikta, Thomas Renné, Sam Schulman, Michael Schwameis, Daniel Strbian, Alfonso Tafur, Julie Vassart, Francesco Violi, Jeanine M. Walenga, Christel Weiß
Abstract
BACKGROUND: With the widespread use of direct oral anticoagulants (DOACs), there is an urgent need for a rapid assay to exclude clinically relevant plasma levels. Accurate and rapid determination of DOAC levels would guide medical decision-making to (1) determine the potential contribution of the DOAC to spontaneous or trauma-induced hemorrhage; (2) identify appropriate candidates for reversal, or (3) optimize the timing of urgent surgery or intervention. METHODS AND RESULTS: The DOAC Dipstick test uses a disposable strip to identify factor Xa- or thrombin inhibitors in a urine sample. Based on the results of a systematic literature search followed by an analysis of a simple pooling of five retrieved clinical studies, the test strip has a high sensitivity and an acceptably high negative predictive value when compared with levels measured with liquid chromatography tandem mass spectrometry or calibrated chromogenic assays to reliably exclude plasma DOAC concentrations ≥30 ng/mL. CONCLUSION: Based on these data, a simple algorithm is proposed to enhance medical decision-making in acute care indications useful primarily in hospitals not having readily available quantitative tests and 24/7. This algorithm not only determines DOAC exposure but also differentiates between factor Xa and thrombin inhibitors to better guide clinical management.