Use of DOAC Dipstick point-of-care testing in patients with acute stroke and transient ischemic attack

Introduction: In the setting of acute stroke and transient ischemic attack (TIA), information about the plasma concentrations of direct oral anticoagulants (DOAC) is critical for further treatment decision. Standard coagulation assays are either not sufficiently reliable or have long turn-around times. In contrast, the DOAC Dipstick is a urine-based point-of-care test which delivers qualitative information about the presence of therapeutically relevant plasma levels of direct oral factor Xa- (DXI) and thrombin inhibitors (DTI) within 10 min on the test strips containing separate pads with immobilized reagents for determination of DXI and DTI. This study aimed to test the feasibility of the DOAC Dipstick among patients with acute stroke and TIA in a stroke unit.

Method: In patients with acute stroke or TIA with symptom onset within 24 hours of hospital admission, a urine sample was obtained within the first 8 hours after hospitalization (inclusion criteria). DOAC Dipstick test was performed from the urine samples and test strips were analysed after incubation visually (via the colour of DXI and DTI pads of the test strips) and with a semiautomated reader by investigators. Investigators for the visual test result were blinded to the reader result. Biographic data and test results were documented on case report forms and analysed by SAS-Software. Among primary endpoints were the success rate of evaluable pad results and time results.

Results: From January 2023 to April 2024, 70 patients were recruited, of which 66 (39% female, age 73,0±11,9 years, mean, standard deviation) fulfilled inclusion criteria. The median time from urine samples to visual and reader test pad results were 20 min visually (minimum-maximum 10-141 min) and 24 min (10-141 min), respectively. Uncomplicated test procedure occurred in 90,9% of patients (n=60). Urine sampling was delayed (n=3), test strips had to be repeated due drying of urine on the pads, and visual test result was not evaluable with absolute certainty (n=1). Urine sample was obtained outside of first 8 hours after hospitalization (n=1), leaving 65 patients for test result analysis. Urine of all patients with prior DOAC intake (n=26), the test pads and the reader showed positive results (DXI pad: n=16 apixaban, n=6 rivaroxaban n=2 edoxaban, DTI pad: n=2 dabigatran). Among all patients without prior DOAC intake (n=39), visual and reader DXI and DTI pad results were negative.

Conclusion: In conclusion, patients with acute stroke or TIA, DOAC Dipstick delivers rapid test results. Problems concerning urine sampling or the test procedure occurred in individual cases. However, the test seems to be an appropriate support in making treatment decisions, such as systemic thrombolysis.

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Artikel online veröffentlicht:
13. Februar 2025