scholarly journals Analytical verification and comparison of chromogenic assays for dabigatran, rivaroxaban and apixaban determination on BCSXP and STA Compact Max analysers

2020 ◽  
Vol 30 (1) ◽  
pp. 110-117
Author(s):  
Ivana Ćelap ◽  
Sandra Margetić ◽  
Marija Brčić ◽  
Roman Mihić
Keyword(s):  
Regression Analysis ◽  
Concentration Level ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Analytical Performance ◽  
Limit Of Quantification ◽  
Significant Bias ◽  
Performance Specifications ◽  
Analytical Verification

Introduction: The aim of the study was to perform analytical verification and comparison of chromogenic assays for determination of dabigatran, rivaroxaban and apixaban concentration on BCSXP and STA Compact Max analysers. Materials and methods: Precision, linearity, measurement uncertainty estimation and determination of limit of blank, limit of determination and limit of quantification were calculated. Analytical performance specifications were set according to manufacturer specifications and literature data on between laboratory variability. Comparison of the methods was done using Bland-Altman and Passing-Bablok regression analysis. Results: Obtained results have shown acceptable precision on STA Compact Max only for dabigatran (CV = 3.5%) at lower concentration level comparing to manufacturer declaration (CV = 3.6%). On BCSXP, the highest coefficient of variation has been shown for apixaban (6.1%) at lower concentration level. Within laboratory precision was not met on STA Compact Max for all assays. Bland-Altman analysis has shown statistically significant bias for dabigatran (23.2%, 95%CI 11.2 – 35.3; P < 0.001) and apixaban (8.4%, 95%CI 1.2 – 15.6; P = 0.023). Passing-Bablok regression analysis has shown systematic and proportional deviation between methods for rivaroxaban (y = 6.52 (2.94 to 11.83) + 0.84 (0.80 to 0.89) x. Conclusion: Chromogenic assays for dabigatran, rivaroxaban and apixaban on BCSXP and STA Compact Max analysers are shown as methods with satisfactory long-term analytical performance specifications for determination of direct oral anticoagulants in clinical laboratories. However, we cannot recommend interchangeable use because of the significant bias between assays.

scholarly journals Determination of Direct Oral Anticoagulants from Human Serum Samples

2013 ◽  
Vol 40 (01) ◽  
pp. 129-134
Author(s):  
Sandra Kraemer ◽  
Shanshan Du ◽  
Christina Giese ◽  
Astrid Schulze ◽  
Roland Kraemer ◽  
...  
Keyword(s):  
Human Serum ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Serum Samples ◽  
Human Serum Samples

Determination of anticoagulant activity of direct oral anticoagulants: the current state of knowledge and a single center experience

2017 ◽  
Vol 53 (3) ◽  
pp. 161-168
Author(s):  
Tadeusz Góralczyk ◽  
Anetta Undas
Keyword(s):  
Anticoagulant Activity ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Thrombin Time ◽  
Routine Laboratory ◽  
Pharmacological Mechanism ◽  
Emergency Procedures ◽  
Single Center Experience

Direct oral anticoagulants (DOACs) increasingly replace vitamin K antagonists in the treatment and prevention of venous thromboembolism, and stroke prevention in non-valvular atrial fibrillation. Due to their predictable pharmacological mechanism, no diet restrictions and lack of interaction with most drugs, DOACs do not require routine laboratory monitoring. However, in cases of suspected concentrations beyond the expected range or a need for an emergent surgical procedure, access to laboratory methods for reliable DOACs determination is necessary. In a routine laboratory, the anticoagulant effect of dabigatran can be determined using methods based on ecarin or the modified dilute thrombin time. Rivaroxaban, apixaban and edoxaban may be measured using the chromogenic anti-FXa assays. Our own experience (the longest in Poland) from the John Paul II Hospital laboratory with the 24-hour availability of DOACs measurement involves determinations of dabigatran (n = 136), rivaroxaban (n = 374) and apixaban (n = 22) in outpatients and hospitalized patients between May 2013 and April 2017. Determination of the level of DOACs should be available 24/7 in highly specialized medical centers, especially in those which perform emergency procedures for treating patients with acute stroke and hemorrhages.

Efficiency of the Left Atrial Appendage Thrombus Dissolution in Patients with Persistent Nonvalvular Atrial Fibrillation with Warfarin or Direct Oral Anticoagulants Therapy

2021 ◽  
Vol 17 (5) ◽  
pp. 724-728
Author(s):  
E. S. Mazur ◽  
V. V. Mazur ◽  
N. D. Bazhenov ◽  
Yu. A. Orlov
Keyword(s):  
Atrial Fibrillation ◽  
Regression Analysis ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Atrial Appendage ◽  
Nonvalvular Atrial Fibrillation ◽  
Left Atrial Appendage Thrombus ◽  
Echocardiographic Examination

Aim. Compare the incidence of the left atrial appendage (LAA) thrombus dissolution in patients with persistent nonvalvular atrial fibrillation receiving warfarin and direct oral anticoagulants (DOAC).Materials and methods. 68 patients with persistent nonvalvular atrial fibrillation were included in a retrospective study (age was 59.7±9.8 years, 60.3% men), in whom at least one repeated transesophageal echocardiographic examination was performed after detecting a thrombus. After detecting a thrombus in the LAA, 37 (54.4%) patients started or continued taking warfarin in doses that ensure the INR maintenance at the level of 2-3, 14 (20.6%) started or continued taking dabigatran at a dose of 150 mg 2 times/day, 14 (20.6%) started or continued taking rivaroxaban 20 mg 1 time/day and 3 (4.4%) started or continued taking apixaban 5 mg 2 times/day. Repeated transesophageal echocardiographic examination was performed on average 33.3±14.2 days after the first one.Results. Dissolution of a previously identified thrombus was found in 26 (83.9%) of 31 patients receiving DOAC and in 19 (51.4%) of 37 patients receiving warfarin (p=0.011). The logistic regression analysis showed that the chances of a thrombus dissolution in LAA while taking DOAC are 14.8 times (95% confidence interval [CI] was 2.469-88.72) higher than while taking warfarin. The size and the rate at which blood is expelled from the LAA also have an independent influence on the chances of thrombus dissolution. An increase in the size of a thrombus by 1 mm reduces the chances of a thrombus dissolution by 1.136 (95% CI was 1.040-1.244) times, and an increase in the rate of blood expulsion from the LAA by 1 cm/sec increases these chances by 1.105 (95% CI was 1.003-1.219) times.Conclusion. In the present study, the incidence of the LAA thrombus dissolution in patients with persistent nonvalvular atrial fibrillation while receiving DOAC was higher than while receiving warfarin.

Discrepancies between the use of MDRD-4 IDMS and CKD-EPI equations, instead of the Cockcroft–Gault equation, in the determination of the dosage of direct oral anticoagulants in patients with non-valvular atrial fibrillation

2018 ◽  
Vol 150 (3) ◽  
pp. 85-91
Author(s):  
Alejandro Isidoro Pérez Cabeza ◽  
Pedro Antonio Chinchurreta Capote ◽  
Jose Antonio González Correa ◽  
Francisco Ruiz Mateas ◽  
Gabriel Rosas Cervantes ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants

scholarly journals Safety of direct oral anticoagulants in older adults with atrial fibrillation: a systematic review and meta-analysis of (subgroup analyses from) randomized controlled trials

2021 ◽  
Author(s):  
Katharina Doni ◽  
Stefanie Bühn ◽  
Alina Weise ◽  
Nina-Kristin Mann ◽  
Simone Hess ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Older Adults ◽  
Low Dose ◽  
Meta Analysis ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
High Dose ◽  
Meta Analyses

Abstract PurposeOur objective was to assess the safety of long-term intake of DOACs in older adults with atrial fibrillation (AF). MethodsWe included RCTs in elderly (≥65 years) patients with AF. A systematic search in MEDLINE and EMBASE was performed on 9/11/2020. For determination of risk of bias, the RoB-2 tool was applied. We pooled outcomes using random-effects meta-analyses. The quality of evidence was assessed using GRADE.ResultsTen RCTs with a total of 61,948 patients were identified. Seven RCTs included patients with AF-only and three with AF who received PCI and additional antiplatelet-therapy. Two RCTs compared apixaban with either warfarin or aspirin, three edoxaban with either placebo, aspirin, or Vitamin K antagonists (VKAs), two dabigatran with warfarin and three rivaroxaban with warfarin. DOACs probably reduce mortality in elderly patients with AF-only (HR 0.89 95%CI 0.78 to 1.02). We did not find any RCT that reported mortality in elderly AF-PCI patients. Low-dose DOACs likely reduce bleeding compared to VKAs (HR ranged from 0.47 to 1.01). High-dose edoxaban reduces major or clinically relevant bleeding (MCRB) compared to VKAs (HR 0.82 95%CI 0.73 to 0.93) but high-dose dabigatran or rivaroxaban increase MCRB (HR 1.15 95%CI 1.02 to 1.30).Conclusion We found that low-dose DOACs probably decrease mortality in AF-only patients. Moreover, apixaban and edoxaban are associated with fewer MCRB compared to VKAs. For dabigatran and rivaroxaban, the risk of MCRB varies depending on dose.

scholarly journals Analytical Spectrometric Study For Determining Dapagliflozin Propanediol Monohydrate Individually Or In Presence Of Metformin Hydrochloride In Tablets Formulation

2020 ◽  
Vol 17 ◽  
pp. 80-87
Author(s):  
SAAD ANTAKLI ◽  
Raghad Kabbani ◽  
And Rama Labban
Keyword(s):  
Regression Analysis ◽  
Spectrophotometric Method ◽  
Limit Of Detection ◽  
Correlation Coefficients ◽  
Metformin Hydrochloride ◽  
Spectrometric Study ◽  
Limit Of Quantification ◽  
First Derivative ◽  
Linearity Range

First simple spectrophotometric method was developed and applied to determine Dapagliflozin Propanediol  Monohydrate by Zero Spectrophotometry and First Derivative Spectrophotometric method for determining of Dapagliflozin Propanediol Monohydrate (DAPA) in the presence of Metformin Hydrochloride (MET). Zero spectrophotometric (ZS) was applied for the determination of (DAPA) at 223.5 nm. Linearity range was (2.61– 31.23) µg/mL. Regression analysis showed a good correlation coefficients R2 = 0.9989. The limit of detection (LOD) and limit of quantification (LOQ) were to be 0.569 µg/mL and 1.724 µg/mL, respectively. Derivative spectrophotometric (1DS) was applied for the determination of (DAPA) in the presence (MET). (DAPA) was determined at 233 nm (1D233).  Linearity ranges were (5.21 – 41.64) µg/mL for (DAPA). Regression analysis showed a good correlation coefficients R2 = 0.9994. The limit of detection (LOD) and limit of quantification (LOQ) were to be 0.732 µg/mL and 2.218 µg/mL for (DAPA). The proposed Zero spectrophotometry method was applied to analysis individual (DAPA), and the derivative (1D233) method was applied to analysis (DAPA) individually or with (MET) combination in Syrian trademark drugs.

scholarly journals Determination of Direct Oral Anticoagulants in Forensic Toxicology

2020 ◽  
Vol 71 (1) ◽  
pp. 308-312
Author(s):  
Marius Neagu ◽  
Ana Fulga ◽  
Anca-Iulia Neagu ◽  
Diana Bulgaru-Iliescu ◽  
Ana-Maria Ciubara ◽  
...  
Keyword(s):  
Mass Spectrometry ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Forensic Toxicology ◽  
Secondary Prophylaxis ◽  
Liquid Chromatography Mass Spectrometry ◽  
Antithrombotic Agents ◽  
Ideal Method ◽  
The Ideal

Oral anticoagulants have been used for more than 50 years as antithrombotic agents, particularly in the primary and secondary prophylaxis of thromboembolic disorders. Our study�s purpose is to synthetize and analyze the toxicological methods used to determine the oral anticoagulants, described in the literature, so we can identify the optimal methods, taking into consideration the diversity of forensic medicine workload. In the electronic databases, for the period 1990-2019, there were identified 56 articles that included the searched keywords. Of these, 28 were included in our study. We excluded the articles that were not lining up with the objective of our study, the update-type articles and the case studies. After analyzing the literature, it was observed that liquid chromatography-mass spectrometry is the ideal method for detecting low-dosed drugs, such as oral anticoagulants.

scholarly journals Development and validation of an analytical method for the determination of direct oral anticoagulants (DOAC) and the direct thrombin-inhibitor argatroban by HPLC–MS/MS

2021 ◽  
Author(s):  
Lea Brückner ◽  
Jan Beyer-Westendorf ◽  
Oliver Tiebel ◽  
Jörg Pietsch
Keyword(s):  
Dabigatran Etexilate ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Simultaneous Detection ◽  
Body Fluids ◽  
Thrombin Inhibitor ◽  
Therapeutic Drug ◽  
Phase System ◽  
The Matrix

AbstractSince direct oral anticoagulants (DOAC) are administered frequently to an elderly, co-morbid population, medical emergencies including trauma, acute bleeding or organ failure are not uncommon. In these situations, the type, dosage or the time of last intake of anticoagulants is often unknown and single substance analysis by functional tests is only possible if the substance contained in the sample is known. A reliable and validated toxicology screen of DOAC and argatroban would be helpful inform not only attending physicians in the emergency department but also law enforcement and courts of justice. After precipitation with acetone, HPLC separation was achieved on a Phenomenex Luna Pentafluorophenyl Colum using acetonitrile–water (90:10, v/v) as mobile phase system. Detection was performed using a 3200 Q Trap mass spectrometer (AB Sciex). For analysis MRM Scans (MS/MS) with positive ionization were chosen. The method was validated for blank serum as the matrix of choice. Limits of detection are between 0.5 and 1.0 ng/mL, limits of quantification are between 1.9 and 3.6 ng/mL and recoveries are above 60%. The applicability of the method was demonstrated by the determination of DOAC in body fluids from forensic cases and in therapeutic drug monitoring. The rapid simultaneous detection and quantification of apixaban, argatroban, dabigatran etexilate, dabigatran, edoxaban and rivaroxaban in body fluids by HPLC–MS/MS closes an important gap in emergency toxicology.

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