A New Test for the Detection of Direct Oral Anticoagulants (Rivaroxaban and Apixaban) in the Emergency Room Setting
Determining whether a patient has taken a direct oral anticoagulant (DOAC) is critical during the periprocedural and preoperative period in the emergency department. However, the inaccessibility of complete medical records, along with the generally inconsistent sensitivity of conventional coagulatio...
| Main Authors: | , , , , , , , , , , , , |
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| Other Authors: | |
| Format: | Article |
| Language: | English |
| Published: |
Ovid Technologies (Wolters Kluwer Health)
2020
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| Online Access: | https://hdl.handle.net/1721.1/128674 |
| _version_ | 1811087421382590464 |
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| author | Frydman, Galit H. Ellett, Felix Van Cott, Elizabeth M. Hayden, Douglas Majmudar, Maulik Vanderburg, Charles R. Dalzell, Haley Padmanabhan, Divya L. Davis, Nick Jorgensen, Julianne Toner, Mehmet Fox, James G Tompkins, Ronald G. |
| author2 | Massachusetts Institute of Technology. Division of Comparative Medicine |
| author_facet | Massachusetts Institute of Technology. Division of Comparative Medicine Frydman, Galit H. Ellett, Felix Van Cott, Elizabeth M. Hayden, Douglas Majmudar, Maulik Vanderburg, Charles R. Dalzell, Haley Padmanabhan, Divya L. Davis, Nick Jorgensen, Julianne Toner, Mehmet Fox, James G Tompkins, Ronald G. |
| author_sort | Frydman, Galit H. |
| collection | MIT |
| description | Determining whether a patient has taken a direct oral anticoagulant (DOAC) is critical during the periprocedural and preoperative period in the emergency department. However, the inaccessibility of complete medical records, along with the generally inconsistent sensitivity of conventional coagulation tests to these drugs, complicates clinical decision making and puts patients at risk of uncontrollable bleeding. In this study, we evaluate the utility of inhibitor-II-X (i-II-X), a novel, microfluidics-based diagnostic assay for the detection and identification of Factor Xa inhibitors (FXa-Is) in an acute care setting. Design: First-in-human, 91-patient, single-center retrospective pilot study. Setting: Emergency room. Patients: Adult patients admitted into the emergency department, which received any clinician-ordered coagulation test requiring a 3.2% buffered sodium citrate blood collection tube. Interventions: None. Measurements and Main Results: Plasma samples from patients admitted to the emergency department were screened for the use of FXa-Is, including apixaban and rivaroxaban, within the past 24 hours using our new i-II-X microfluidic test. i-II-X results were then compared with results from conventional coagulation tests, including prothrombin time (PT) and international normalized ratio (INR), which were ordered by treating clinicians, and an anti-Xa assay for rivaroxaban. The i-II-X test detected DOACs in samples collected from the emergency department with 95.20% sensitivity and 100.00% specificity. Unlike PT and INR, i-II-X reliably identified patients who had prolonged clotting times secondary to the presence of a FXa-I. Conclusions: The i-II-X test overcomes the limitations of currently available coagulation tests and could be a useful tool by which to routinely screen patients for DOACs in emergency and critical care settings. Our new diagnostic approach is particularly relevant in clinical situations where medical records may be unavailable, or where precautions need to be taken prior to invasive interventions, such as specific reversal agent administration. |
| first_indexed | 2024-09-23T13:45:49Z |
| format | Article |
| id | mit-1721.1/128674 |
| institution | Massachusetts Institute of Technology |
| language | English |
| last_indexed | 2024-09-23T13:45:49Z |
| publishDate | 2020 |
| publisher | Ovid Technologies (Wolters Kluwer Health) |
| record_format | dspace |
| spelling | mit-1721.1/1286742022-09-28T16:02:12Z A New Test for the Detection of Direct Oral Anticoagulants (Rivaroxaban and Apixaban) in the Emergency Room Setting Frydman, Galit H. Ellett, Felix Van Cott, Elizabeth M. Hayden, Douglas Majmudar, Maulik Vanderburg, Charles R. Dalzell, Haley Padmanabhan, Divya L. Davis, Nick Jorgensen, Julianne Toner, Mehmet Fox, James G Tompkins, Ronald G. Massachusetts Institute of Technology. Division of Comparative Medicine Massachusetts Institute of Technology. Department of Biological Engineering Determining whether a patient has taken a direct oral anticoagulant (DOAC) is critical during the periprocedural and preoperative period in the emergency department. However, the inaccessibility of complete medical records, along with the generally inconsistent sensitivity of conventional coagulation tests to these drugs, complicates clinical decision making and puts patients at risk of uncontrollable bleeding. In this study, we evaluate the utility of inhibitor-II-X (i-II-X), a novel, microfluidics-based diagnostic assay for the detection and identification of Factor Xa inhibitors (FXa-Is) in an acute care setting. Design: First-in-human, 91-patient, single-center retrospective pilot study. Setting: Emergency room. Patients: Adult patients admitted into the emergency department, which received any clinician-ordered coagulation test requiring a 3.2% buffered sodium citrate blood collection tube. Interventions: None. Measurements and Main Results: Plasma samples from patients admitted to the emergency department were screened for the use of FXa-Is, including apixaban and rivaroxaban, within the past 24 hours using our new i-II-X microfluidic test. i-II-X results were then compared with results from conventional coagulation tests, including prothrombin time (PT) and international normalized ratio (INR), which were ordered by treating clinicians, and an anti-Xa assay for rivaroxaban. The i-II-X test detected DOACs in samples collected from the emergency department with 95.20% sensitivity and 100.00% specificity. Unlike PT and INR, i-II-X reliably identified patients who had prolonged clotting times secondary to the presence of a FXa-I. Conclusions: The i-II-X test overcomes the limitations of currently available coagulation tests and could be a useful tool by which to routinely screen patients for DOACs in emergency and critical care settings. Our new diagnostic approach is particularly relevant in clinical situations where medical records may be unavailable, or where precautions need to be taken prior to invasive interventions, such as specific reversal agent administration. 2020-11-30T15:38:44Z 2020-11-30T15:38:44Z 2019-08 2020-05-04T19:45:20Z Article http://purl.org/eprint/type/JournalArticle 2639-8028 https://hdl.handle.net/1721.1/128674 Frydman, Galit H. et al. "A New Test for the Detection of Direct Oral Anticoagulants (Rivaroxaban and Apixaban) in the Emergency Room Setting." Critical Care Explorations 1, 8 (August 2019): e0024. © 2019 The Authors en http://dx.doi.org/10.1097/cce.0000000000000024 Critical Care Explorations Creative Commons Attribution-NonCommercial-NoDerivs License http://creativecommons.org/licenses/by-nc-nd/4.0/ application/pdf Ovid Technologies (Wolters Kluwer Health) Wolters Kluwer |
| spellingShingle | Frydman, Galit H. Ellett, Felix Van Cott, Elizabeth M. Hayden, Douglas Majmudar, Maulik Vanderburg, Charles R. Dalzell, Haley Padmanabhan, Divya L. Davis, Nick Jorgensen, Julianne Toner, Mehmet Fox, James G Tompkins, Ronald G. A New Test for the Detection of Direct Oral Anticoagulants (Rivaroxaban and Apixaban) in the Emergency Room Setting |
| title | A New Test for the Detection of Direct Oral Anticoagulants (Rivaroxaban and Apixaban) in the Emergency Room Setting |
| title_full | A New Test for the Detection of Direct Oral Anticoagulants (Rivaroxaban and Apixaban) in the Emergency Room Setting |
| title_fullStr | A New Test for the Detection of Direct Oral Anticoagulants (Rivaroxaban and Apixaban) in the Emergency Room Setting |
| title_full_unstemmed | A New Test for the Detection of Direct Oral Anticoagulants (Rivaroxaban and Apixaban) in the Emergency Room Setting |
| title_short | A New Test for the Detection of Direct Oral Anticoagulants (Rivaroxaban and Apixaban) in the Emergency Room Setting |
| title_sort | new test for the detection of direct oral anticoagulants rivaroxaban and apixaban in the emergency room setting |
| url | https://hdl.handle.net/1721.1/128674 |
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