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      A review of the clinical utility of INR to monitor and guide administration of prothrombin complex concentrate to orally anticoagulated patients

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          Abstract

          Background and objectives

          The number of patients treated with oral anticoagulation (OAC) is increasing and these patients are monitored by International Normalized Ratio (INR). Bleeding complications are common and we speculate if this is related to the limitation of INR only reflecting the initiation steps of the haemostatic process. The objective of the present review was to reassess the evidence for using INR as a tool to guide administration of prothrombin complex concentrates (PCC) to OAC patients. A Medline and Cochrane database search was conducted using the following keywords: prothrombin complex concentrate, reversal of oral anticoagulation and international normalized ratio (INR). Thirty-three articles were contracted and a total of ten studies were eligible after applying inclusion and exclusion criteria encompassing only 339 patients. No consensus regarding optimal target INR value to aim for when reversing OAC was found. In three of the studies it was reported that patients reaching their target INR continued to bleed, whereas three studies reviewed reported good haemostatic response also in patients that did not reach their target INR. The present review found limited evidence for the usefulness of INR as a tool to monitor and guide reversal of OAC induced coagulopathy in patients with PCC, which is expected given that it is a plasma-based assay only reflecting a limited part of the haemostatic process.

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          Most cited references25

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          Bleeding complications with warfarin use: a prevalent adverse effect resulting in regulatory action.

          Warfarin sodium is widely used and causes bleeding; a review might suggest the need for regulatory action by the US Food and Drug Administration (FDA). We accessed warfarin prescriptions from the National Prescription Audit Plus database of IMS Health (Plymouth Meeting, Pennsylvania), adverse event reports submitted to the FDA, deaths due to therapeutic use of anticoagulants from vital statistics data, and warfarin bleeding complications from national hospital emergency department data. The number of dispensed outpatient prescriptions for warfarin increased 45%, from 21 million in 1998 to nearly 31 million in 2004. The FDA's Adverse Event Reporting System indicated that warfarin is among the top 10 drugs with the largest number of serious adverse event reports submitted during the 1990 and 2000 decades. From US death certificates, anticoagulants ranked first in 2003 and 2004 in the number of total mentions of deaths for drugs causing "adverse effects in therapeutic use." Data from hospital emergency departments for 1999 through 2003 indicated that warfarin was associated with about 29 000 visits for bleeding complications per year, and it was among the drugs with the most visits. These data are consistent with literature reports of major bleeding frequencies for warfarin as high as 10% to 16%. Use of warfarin has increased, and bleeding from warfarin use is a prevalent reaction and an important cause of mortality. Consequently, a "black box" warning about warfarin's bleeding risk was added to the US product labeling in 2006. Physicians and nurses should tell patients to immediately report signs and symptoms of bleeding. A Medication Guide, which is required to be provided with each prescription, reinforces this message.
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            Medication use leading to emergency department visits for adverse drug events in older adults.

            The Beers criteria identify inappropriate use of medications in older adults. The number of and risk for adverse events from these medications are unknown. To estimate the number of and risk for emergency department visits for adverse events involving Beers criteria medications compared with other medications. Nationally representative, public health surveillance of adverse drug events and a cross-sectional survey of outpatient medical visits. National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance System, 2004-2005; National Ambulatory Medical Care Survey, 2004; and National Hospital Ambulatory Medical Care Survey, 2004. Persons 65 years of age or older seeking emergency department and outpatient care. Estimated number of and risks for emergency department visits for adverse drug events involving Beers criteria medications and other medications. Among U.S. patients 65 years of age or older, an estimated 177,504 emergency department visits (95% CI, 100,155 to 254,854 visits) for adverse drug events occurred both years. An estimated 3.6% (CI, 2.8% to 4.5%) of these visits were for adverse events medications considered to be always potentially inappropriate, according to the Beers criteria, and 33.3% (CI, 27.8% to 38.7%) of visits were for adverse events from 3 other medications (warfarin [17.3%], insulin [13.0%], and digoxin [3.2%]). Accounting for outpatient prescription frequency, the risk for emergency department visits for adverse events due to these 3 medications was 35 times (CI, 9.6 to 61) greater than that for medications considered to be always potentially inappropriate. Adverse events were identified only in emergency departments. Compared with other medications, Beers criteria medications caused low numbers of and few risks for emergency department visits for adverse events. Performance measures and interventions targeting warfarin, insulin, and digoxin use could prevent more emergency department visits for adverse events.
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              Paucity of studies to support that abnormal coagulation test results predict bleeding in the setting of invasive procedures: an evidence-based review.

              The literature was systematically reviewed to determine whether a prolonged prothrombin time or elevated international normalized ratio predicts bleeding during invasive diagnostic procedures. MEDLINE and CENTRAL were searched through August 2004, with no language restriction, and reference lists were reviewed. For inclusion, articles must have reported on bleeding in more than five patients with abnormal test results undergoing diagnostic procedures. One trial and 24 observational studies were included. In 2 studies of bronchoscopy, the bleeding rates were similar among those with normal and abnormal tests, with wide confidence intervals (CIs) around the risk differences. During central vein cannulation (3 studies), bleeding rates among those with abnormal tests was unlikely to exceed 2.3 percent. The largest of 3 studies of arteriography found equivalent bleeding rates in patients with and without abnormal tests (risk difference, 0%; 95% CI, -3% to 2%). In the 3 studies of liver biopsy with plugging, bleeding rates were 0, 4, and 5 percent with the upper bounds of the CI as high as 17 percent. In the largest study of transjugular biopsy, the bleeding rate was 1.5 percent (95% CI, 0.3%-4%) in patients with abnormal tests. The highest bleeding rate in the 3 studies of percutaneous liver biopsy was 5.3 percent (95% CI, 1%-13%), similar to the rate in patients with normal test results. There is insufficient evidence to conclude that abnormal test results predict bleeding. Randomized controlled trials should be performed to provide stronger evidence for clinical decision making regarding preprocedure transfusion.
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                Author and article information

                Journal
                Thromb J
                Thromb J
                Thrombosis Journal
                BioMed Central
                1477-9560
                2012
                30 April 2012
                : 10
                : 5
                Affiliations
                [1 ]Section for Transfusion Medicine, Capital Region Blood Bank, Rigshospitalet University of Copenhagen, Blegdamsvej 9, DK-2100, Copenhagen, Denmark
                Article
                1477-9560-10-5
                10.1186/1477-9560-10-5
                3413545
                22546056
                770b992e-aee0-4fb9-820d-e1de239a286b
                Copyright ©2012 Sølbeck et al.; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 19 August 2011
                : 30 April 2012
                Categories
                Original Clinical Investigation

                Cardiovascular Medicine
                anticoagulation reversal,pcc,inr,oac,haemostatic efficacy
                Cardiovascular Medicine
                anticoagulation reversal, pcc, inr, oac, haemostatic efficacy

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