scholarly journals Adverse Events Following International Normalized Ratio Reversal in Intracerebral Hemorrhage

2016 ◽  
Vol 42 (5-6) ◽  
pp. 446-454 ◽  
Author(s):  
Mona Laible ◽  
Ekkehart Jenetzky ◽  
Christopher Beynon ◽  
Oliver Josef Müller ◽  
Peter Sander ◽  
...  
Keyword(s):  
Intracerebral Hemorrhage ◽  
Clinical Characteristics ◽  
Point Of Care ◽  
Vitamin K Antagonists ◽  
International Normalized Ratio ◽  
Thromboembolic Events ◽  
Prothrombin Complex Concentrates ◽  
Factors Associated ◽  
Before And After ◽  
High Doses

Background: Prothrombin complex concentrates (PCCs) are frequently used to reverse the effect of vitamin K antagonists (VKAs) in patients with non-traumatic intracerebral hemorrhage (ICH). However, information on the rate of thromboembolic events (TEs) and allergic events after PCC therapy in VKA-ICH patients is limited. Methods: Consecutive VKA-ICH patients treated with PCC at our institution between December 2004 and June 2014 were included into this retrospective observational study. We recorded international normalized ratio (INR) values before and after PCC treatment, baseline clinical characteristics including the premorbid modified Rankin Scale (pmRS) score, TE and allergic event that occurred during the hospital stay. All events were classified by 3 reviewers as being ‘related', ‘probably related', ‘possibly related', ‘unlikely related' or ‘not related' to treatment with PCC. To identify factors associated with TEs, log-rank analyses were applied. Results: Two hundred and five patients were included. Median INR was 2.8 (interquartile range (IQR) 2.2-3.8) before and 1.3 (IQR 1.2-1.4) after PCC treatment and a median of 1,500 IU PCC (IQR 1,000-2,500) was administered. Nineteen TEs were observed (9.3%); none were classified ‘related' but 9 were classified as ‘possibly' or ‘probably related' to PCC infusion (4.4%). One allergic reaction (0.5%), ‘unlikely related' to PCC, was observed. In the whole cohort, PCC doses >2,000-3,000 IU, ICH volumes >40 ml, National Institute of Health Stroke Scale values >10 and a pmRS >2 were associated with the development of TEs (p = 0.031, p = 0.034, p = 0.050 and p = 0.036, respectively). Conclusions: Overall, INR reversal with PCC appears safe. Though no clear relationship between higher PCC dosing and TEs was observed, PCC doses between >2,000 and 3,000 IU and higher morbidity at ICH onset were associated with TEs. Hence, individual titration of PCC to avoid exposure to unnecessarily high doses using point-of-care devices should be prospectively explored.

Accuracy of the CoaguChek XS for point-of-care international normalized ratio (INR) measurement in children requiring warfarin

2008 ◽  
Vol 99 (06) ◽  
pp. 1097-1103 ◽  
Author(s):  
Karina Black ◽  
Mary Massicotte ◽  
Michelle Bauman ◽  
Stefan Kuhle ◽  
Susan Howlett-Clyne ◽  
...  
Keyword(s):  
Point Of Care ◽  
Vitamin K Antagonists ◽  
Venous Blood ◽  
International Normalized Ratio ◽  
Test Results ◽  
Standard Laboratory ◽  
Limits Of Agreement ◽  
Time Points ◽  
Coaguchek Xs ◽  
Roche Diagnostics

SummaryPoint-of-care INR (POC INR) meters can provide a safe and effective method for monitoring oral vitamin K antagonists (VKAs) in children. Stollery Children’s Hospital has a large POC INR meter loan program for children requiring oral VKAs. Our protocol requires that POC INR results be compared to the standard laboratory INR for each child on several consecutive tests to ensure accuracy of CoaguChek XS® (Roche Diagnostics, Basel Switzerland) meter. It was the objective of the study to determine the accuracy of the CoaguChek XS by comparing whole blood INR results from the CoaguChek XS to plasma INR results from the standard laboratory in children. POC INR meter validations were performed on plasma samples from two time points from 62 children receiving warfarin by drawing a venous blood sample for laboratory prothrombin (PT)-INR measurements and simultaneous INR determinations using the POC-INR meter. Agreement between CoaguChek XS INR and laboratory INR was assessed using Bland-Altman plots. Bland-Altman's 95% limits of agreement were 0.11 (-0.20; 0.42) and 0.13 (-0.22; 0.48) at the two time points, respectively. In conclusion, the CoaguChek XS meter appraisal generates an accurate and precise INR measure in children when compared to laboratory INR test results.

Point-of-Care Coagulation Tests Monitoring of Direct Oral Anticoagulants and Their Reversal Therapy: State of the Art

2017 ◽  
Vol 43 (04) ◽  
pp. 423-432 ◽  
Author(s):  
Paolo Bianchi ◽  
Marco Ranucci ◽  
Ekaterina Baryshnikova ◽  
Giacomo Iapichino
Keyword(s):  
Point Of Care ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Plasma Concentrations ◽  
Urgent Surgery ◽  
Drug Plasma Concentrations ◽  
Drug Plasma ◽  
Coagulation Tests ◽  
Before And After

AbstractDirect oral anticoagulants (DOACs) exert similar anticoagulant effects to vitamin K antagonists and are increasingly used worldwide. Nevertheless, an evidence-based approach to patients receiving DOACs when any unplanned urgent surgery or bleeding (either spontaneous or traumatic) occurs is still missing. In this review, we investigate the role of point-of-care coagulation tests when other, more specific tests are not available. Indeed, thromboelastography and activated clotting time can detect dabigatran-induced coagulopathy, while their accuracy is limited for apixaban and rivaroxaban, mostly in cases of low drug plasma concentrations. These tests can also be used to guide the reversal of DOAC-induced coagulopathy providing a quick, before-and-after picture in case of therapeutic use of hemostatic compounds.

Prothrombin Complex Concentrates Compared with Frozen Plasma for Urgent Reversal of Vitamin K Antagonists: A Single Centre Retrospective Review

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 4296-4296
Author(s):  
Lauren J. Lee ◽  
Jay Chi ◽  
Kate M. Chipperfield ◽  
Paul R. Yenson
Keyword(s):  
Vitamin K ◽  
Vitamin K Antagonists ◽  
Categorical Variables ◽  
Thromboembolic Events ◽  
Prothrombin Complex Concentrates ◽  
Significant Difference ◽  
Bleeding Episodes ◽  
Chi Square Analysis ◽  
Frozen Plasma ◽  
Transfusion Reactions

Abstract Background: Vitamin K antagonists (VKAs) are associated with a risk of major bleeding requiring urgent reversal with frozen plasma (FP) or prothrombin complex concentrates (PCC) and concurrent vitamin K administration. Several treatment guidelines currently recommend PCC over FP for urgent reversal in VKA-associated bleeding. Four-factor PCC (Octaplex®, Beriplex®) has been available in Canada since 2008 with a change in national dosing recommendations in 2012. We conducted a retrospective study to determine the efficacy and safety of PCC in comparison with FP in patients presenting with bleeding and requiring VKA reversal. Methods: We retrospectively reviewed all consecutive bleeding episodes requiring VKA reversal at Vancouver General Hospital (VGH) for 2 cohorts of patients: i) those who received FP (July 28, 2008 to July 27, 2010); and ii) those who received PCC, during two time periods (July 28, 2008 to July 27, 2010; and September 1, 2011 to December 31, 2012) during which Canadian national dosing recommendations had changed. The PCC data however were pooled as no significant differences between the early and later PCC cohorts were found. Details of VKA reversal were reviewed, including patient demographics, bleeding type, indication for VKA therapy, dose of PCC or FP, admission hematologic parameters, INR value subsequent to completion of PCC or FP infusion, time to complete infusion, transfusion requirements, vitamin K dose and route of administration, transfusion reactions, thrombotic events (within 30 days) and mortality during hospitalization. The primary outcome was the proportion of patients achieving a target INR defined as ≤1.5 following the initial order of PCC or FP. Subject characteristics were compared using two-sided t-tests for continuous and Chi-square analysis for categorical variables. Predictors of mortality were analyzed with binary logistic regression. Results: A total of 201 bleeding episodes occurred in 191 patients. PCC was used in 89 episodes (44%). The most common indication for VKA was atrial fibrillation (81%). Mean PCC dose was 1489 U (range 500-3000 U). Mean FP dose was 3.1 U (range 1-10 U). Target INR was achieved in 86% of episodes in the PCC group versus 60% with FP (p<0.001). Mean time to complete the reversal agent was 4.4 hours with PCC versus 8.7 hours with FP (p<0.001). There was no significant difference in thromboembolic events between FP and PCC with 4 thromboembolic events occurring in each treatment group: 2 strokes, 1 myocardial infarction, and 1 recurrent deep vein thrombosis occurred in the PCC cohort. No transfusion-related reactions occurred in the PCC group compared with 12.6% with FP (p<0.001). Mortality was significantly higher in the PCC group (25% vs. 11%, p=0.010); however, intracranial bleeding (ICH) was more common in the PCC group (62% vs. 31%, p<0.001) and was the only independent predictor of mortality. Vitamin K was not administered in 20% of episodes, including 17% of episodes of ICH. Conclusion: PCC is effective in the urgent reversal of VKA with faster and more complete INR reversal, significantly fewer transfusion reactions and no increase in thromboembolic events in comparison to FP. Along with vitamin K, PCC should be the agent of choice for VKA reversal in bleeding patients. Disclosures Chipperfield: Boehringer Ingelheim: Honoraria. Yenson:Octapharma Canada: Unrestricted Education Grant Other; Alexion Pharmaceuticals: Honoraria.

scholarly journals A New Method for the Measurement of International Normalized Ratio in Hemodialysis Patients with Heparin-Locked Tunneled Dialysis Catheters

2020 ◽  
Vol 2020 ◽  
pp. 1-6
Author(s):  
Céline B. Seghers ◽  
Kristien Ver Elst ◽  
Jolien Claessens ◽  
Steven Weekx ◽  
Sigrid Vermeiren ◽  
...  
Keyword(s):  
Point Of Care ◽  
Vitamin K Antagonists ◽  
International Normalized Ratio ◽  
Hemodialysis Patients ◽  
Blood Sampling ◽  
Wilcoxon Test ◽  
Point Of Care Testing ◽  
Heparin Concentration ◽  
Finger Prick ◽  
Catheter Site

Background. To measure International Normalized Ratio (INR) in hemodialysis patients with tunneled dialysis catheters (TDCs), blood sampling is frequently obtained via the catheter at the start of the session. INR measurements via finger-prick point of care testing (POCT) and via blood sampling taken from the dialysis circuit are evaluated as alternatives. Methods. In 14 hemodialysis patients with TDCs, treated with vitamin K antagonists (VKA), INR measurements via POCT were compared with plasma INR samples taken via the catheter at the start of dialysis and via the dialysis circuit after 30 and 60 minutes during 3 nonconsecutive dialysis sessions. Results. Blood samples taken at the start of dialysis at the catheter site were frequently contaminated with heparin originating from the locking solution (unfractionated heparin concentration (UFH) >1.0 IU/ml in 13.2%). POCT INR at the start of dialysis was not different from plasma INR after 30 and 60 minutes (Wilcoxon test p = 0.113 , n = 37, and p = 0.631 , n = 36, respectively). Moreover, there was no difference between POCT INR at the start of dialysis and POCT INR after 30 and 60 minutes (Wilcoxon test p = 0.797 and p = 0.801, respectively; n = 36). Passing and Bablok regression equation was used, y = 0.460 + 0.733x; n = 105. Treatment decisions based on these 2 methods showed a very good overall agreement (kappa = 0.810; 95% CI: 0.732–0.889; n = 105). Conclusions. Measuring plasma INR via the TDC at the start of dialysis should be abandoned. Measuring POCT INR via a finger prick at the start or even after 30 to 60 minutes is an alternative. The most elegant alternative is to take plasma INR samples via the dialysis circuit 30 minutes or later after the start of the dialysis.

SAFETY of PROTHROMBIN COMPLEX CONCENTRATES IN PATIENTS REQUIRING RAPID REVERSAL of ANTICOAGULANT TREATMENT with the VITAMIN K ANTAGONISTS: a Systematic Review and a Meta-Analysis of the Literature.

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 1113-1113
Author(s):  
Francesco Dentali ◽  
Chiara Marchesi ◽  
Matteo Giorgi Pierfranceschi ◽  
Mark A. Crowther ◽  
David Garcia ◽  
...  
Keyword(s):  
Systematic Review ◽  
Vitamin K ◽  
Research Funding ◽  
Vitamin K Antagonists ◽  
Viral Transmission ◽  
Thromboembolic Events ◽  
Thromboembolic Complications ◽  
Review Of The Literature ◽  
Weighted Mean ◽  
Prothrombin Complex Concentrates

Abstract Abstract 1113 Background: Prothrombin complex concentrates (PCCs) are currently recommended by several international guidelines as the treatment of choice in warfarin-related coagulopathy. However, while the efficacy of PCCs is well established, their safety in terms of risk of thromboembolic complications, some of which may be severe or even life-threatening, is still not clear. Thus, we performed a systematic review of the literature with the aim of evaluating the rate of thromboembolic complications in patients on Vitamin K antagonists (VKAs) treated with PCCs for a bleeding event or before an urgent invasive procedure. Methods: MEDLINE and EMBASE databases were searched up to June 2010. Two reviewers performed study selection independently. Studies providing data on incidence thromboembolic complications in patients on VKAs were potentially eligible for the study. Two reviewers independently extracted data on study and population characteristics, type, dose of PCC treatment. Weighted mean proportion of the rate of thromboembolic complications and the mortality rate were calculated. Results: 28 studies for a total of 1104 patients were included in our systematic review. Seven studies used 3-factor PCCs, 21 studies used 4-factor PCCs. Concomitant vitamin K was administered in 21 studies, while fresh frozen plasma in 6. Seventeen patients had a thromboembolic complication after PCCs administration (weighted mean 1.9%; 95% CI 1.1–2.9 %). Of the thromboembolic events, 4 were fatal (23%). The incidence of thromboembolic events was 1.9%; (95% CI 1.0–3.1 %) in patients treated for bleeding and 0.8% (95% CI 0.1–2.0 %) in patients treated before urgent surgery or invasive procedures. For 5 of the reported events we were unable to define the subgroup. The incidence of thromboembolic events was 2.3% (95% CI 1.2–3.8) in patients treated with 4-factor PCCs, and 0.7% (95% CI 0.0–2.4) in patients treated with 3-factor PCCs. One hundred and seven patients died for a mean mortality rate of 11.1% (95% CI 6.4–17.0 %). Only 7 studies for a total 257 patients provided data on the incidence of viral transmission after PCCs administration. In this subgroup of patients there were 4 episode of positivity for parvovirus B19 for a mean incidence of 1.9% (95% CI 0.3–4.9%). Conclusions: The results of our systematic review of the literature show that the treatment with PCCs in patients on VKAs therapy is associated with a low risk of thromboembolic complications providing important information on the safety of this approach. Moreover, also the risk of viral transmission, although evaluated in few studies only, appears to be negligible. The findings of a low thromboembolic risk have been further confirmed by the results of the subgroup analyses separately evaluating treatment with 3 or 4-factors PCCs and different indications for PCCs therapy. Disclosures: Crowther: Pfizer: Consultancy; Leo Pharma: Research Funding; Boehringer Ingelheim: Research Funding.

Vitamin K antagonists

ESC CardioMed ◽  
2018 ◽  
pp. 262-264
Author(s):  
Jørgen Jespersen ◽  
Jane Skov
Keyword(s):  
Vitamin K ◽  
Point Of Care ◽  
Vitamin K Antagonists ◽  
International Normalized Ratio ◽  
World Health ◽  
Computer Assisted ◽  
Clinical Settings ◽  
Self Testing ◽  
Clinical Control ◽  
Health Organization

Vitamin K antagonists are widely used for prevention of thrombosis in patients at high risk. Dosage requirements differ greatly among individuals, and interactions are observed with other pharmaceuticals or dietary compounds, necessitating frequent control of the anticoagulant effect. This can be achieved through monitoring of the international normalized ratio. For providing high-quality treatment with vitamin K antagonists, both laboratory and clinical elements must be optimized. The international normalized ratio is measured in the laboratory or by point-of-care devices, in both cases values according to World Health Organization standardization should be reported and external quality assessment established. Clinical control includes measurements of treatment stability for individual patients and the entire clinic. Novel procedures such as computer-assisted dosage and patient self-testing or self-management can improve clinical quality. The vast existing knowledge of vitamin K antagonists and the ongoing research efforts notwithstanding, treatment of optimal quality is still not achieved in all clinical settings and countries.

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