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Associate Professor of Clinical Pharmacy, Adjunct Associate Professor of Pharmacy in Medicine, Cardiovascular Division, Department of Medicine, Philadelphia College of Pharmacy, University of Pennsylvania, Philadelphia, PA
Clinical Associate Professor, Director, Antithrombosis Services, Department of Pharmacy Practice, College of Pharmacy, The University of Illinois at Chicago, Chicago, IL
Clinical Care Pharmacist, Department of Pharmaceutical Services, William Beaumont Hospital, Royal Oak, MI; Professor of Pharmacy Practice, Wayne State University, Detroit, MI
Professor of Clinical Pharmacy, School of Pharmacy, University of Washington; Director, Anticoagulation Services, University of Washington Medical Center, Seattle, WA
Reprints: Dr. Spinler, 600 S. 43rd St., Philadelphia, PA 19104-4495, fax 215/596-8586, s.spinle{at}usip.edu
OBJECTIVE: To review the availability, mechanisms, limitations, and clinical application of point-of-care (POC) devices used in the management of warfarin and parenteral direct thrombin inhibitors.
DATA SOURCES: Scientific articles were identified through a MEDLINE search (1966–August 2004), manufacturer Web sites, additional references listed in articles and Web sites, and abstracts from scientific meetings.
STUDY SELECTION AND DATA EXTRACTION: English-language literature from clinical trials was reviewed to evaluate the accuracy, reliability, and clinical application of POC monitoring devices.
DATA SYNTHESIS: The prothrombin time expressed as the international normalized ratio (PT–INR) is a well-established test for monitoring warfarin anticoagulation. Multiple devices are available for POC testing. Because there is no universally accepted standard, the performance of each device is typically tested against a standard test performed in a reference laboratory. Performance of currently available devices, as measured by correlations to a standard reference laboratory PT–INR, may be considered very good and acceptable for use in patient care. Utilization of patient self-testing and patient self-monitoring of warfarin anticoagulation using POC devices is increasing. Parenteral direct thrombin inhibitors are typically monitored using a standard laboratory activated partial thromboplastin time. Some research has shown that POC monitoring of direct thrombin inhibitors using the ecarin clotting time is helpful for patients undergoing cardiopulmonary bypass surgery, although that test is not readily available.
CONCLUSIONS: POC testing for anticoagulation therapy has been available for >20 years. Multiple POC devices are available to monitor warfarin. There is some variability in results between devices and between reagents used in the same device. Despite these limitations, POC monitoring of warfarin via the PT–INR is an integral part of clinical practice. Additional research evaluating POC monitoring of direct thrombin inhibitors is necessary.
Key Words: direct thrombin inhibitor, ecarin clotting time, heparin, international normalized ratio, point-of-care testing, prothrombin time, warfarin
Published Online, April 26, 2005. www.theannals.com, DOI 10.1345/aph.1E118
THIS ARTICLE IS APPROVED FOR CONTINUING EDUCATION CREDIT
ACPE UNIVERSAL PROGRAM NUMBER: 407-000-05-018-H01
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  E. A Nutescu, S. A Spinler, A. Wittkowsky, and W. E Dager Low-Molecular-Weight Heparins in Renal Impairment and Obesity: Available Evidence and Clinical Practice Recommendations Across Medical and Surgical Settings Ann. Pharmacother., June 1, 2009; 43(6): 1064 - 1083. [Abstract] [Full Text] [PDF]
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S. A Spinler, A. K Wittkowsky, E. A Nutescu, and M. A Smythe Anticoagulation Monitoring Part 2: Unfractionated Heparin and Low-Molecular-Weight Heparin Ann. Pharmacother., July 1, 2005; 39(7): 1275 - 1285. [Abstract] [Full Text] [PDF]
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