4.3 Review

Grundlagen zur Anwendung von Andexanet

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Article Cardiac & Cardiovascular Systems

Final Study Report of Andexanet Alfa for Major Bleeding With Factor Xa Inhibitors

Jr Tuman J. Milling et al.

Summary: This study evaluated the safety and efficacy of andexanet alfa in patients with major bleeding caused by factor Xa inhibitors. The results showed that the drug reduced anti-FXa activity and achieved good or excellent hemostatic efficacy in 80% of the patients.

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Article Anesthesiology

Bleeding management in patients with direct oral anticoagulants

Lars Heubner et al.

Summary: Bleeding events in patients under DOAC, while not often caused by drug overdose, can be life-threatening. Assessing DOAC plasma concentration is crucial for proper management, but standard coagulation tests are not sufficient. Point-of-care testing, although promising, still needs validation.

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Review Hematology

Thrombin generation for monitoring hemostatic therapy in hemophilia A: A narrative review

Marieke J. A. Verhagen et al.

Summary: Severe hemophilia A patients are at increased risk of bleeding, but using FVIII activity level to monitor treatment may not accurately predict the bleeding risk. Thrombin generation assays offer a better tool for evaluating treatment and monitoring bypassing agents and non-factor replacement therapy.

JOURNAL OF THROMBOSIS AND HAEMOSTASIS (2022)

Article Cardiac & Cardiovascular Systems

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

Lea Brueckner et al.

Summary: Direct oral anticoagulants (DOAC) are commonly used in elderly patients with co-morbidities, leading to medical emergencies such as trauma, acute bleeding, or organ failure. A validated toxicology screen of DOAC and argatroban can provide valuable information to emergency physicians, law enforcement, and courts of justice. The HPLC-MS/MS method for simultaneous detection and quantification of various anticoagulants in body fluids fills an important gap in emergency toxicology.

JOURNAL OF THROMBOSIS AND THROMBOLYSIS (2022)

Article Hematology

DOAC Dipstick Testing Can Reliably Exclude the Presence of Clinically Relevant DOAC Concentrations in Circulation

Sandra Margetic et al.

Summary: This study aimed to determine whether qualitative testing of DOACs in urine samples can exclude clinically relevant plasma levels of DOACs. The study found that DOAC Dipstick testing can reliably exclude the presence of DOACs in urine samples at best-fitting thresholds and determined the best-fit threshold plasma levels using chromogenic substrate assays.

THROMBOSIS AND HAEMOSTASIS (2022)

Article Hematology

Andexanet Alfa for Specific Anticoagulation Reversal in Patients with Acute Bleeding during Treatment with Edoxaban

Alexander P. Benz et al.

Summary: The study found that andexanet significantly decreased antifactor Xa activity and achieved good hemostasis in patients with acute major bleeding on edoxaban. The efficacy was similar to that observed in patients with bleeding on other anticoagulant drugs. The rate of thrombotic events in these patients was as expected.

THROMBOSIS AND HAEMOSTASIS (2022)

Article Hematology

Pharmacokinetics of Direct Oral Anticoagulants in Emergency Situations: Results of the Prospective Observational RADOA-Registry

Edelgard Lindhoff-Last et al.

Summary: The pharmacokinetic data of emergency patients under DOAC treatment showed a high variation of anticoagulant concentrations at baseline. Apixaban exhibited a lower median concentration on admission and a longer half-life compared to rivaroxaban.

THROMBOSIS AND HAEMOSTASIS (2022)

Article Cardiac & Cardiovascular Systems

Accuracy of a Single, Heparin-Calibrated Anti-Xa Assay for the Measurement of Rivaroxaban, Apixaban, and Edoxaban Drug Concentrations: A Prospective Cross-Sectional Study

Tamana Meihandoest et al.

Summary: In this study, a heparin-calibrated anti-Xa assay was found to accurately measure the drug concentrations of rivaroxaban, apixaban, and edoxaban, and correctly predict clinically relevant levels.

FRONTIERS IN CARDIOVASCULAR MEDICINE (2022)

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Applicability of the Thrombin Generation Test to Evaluate the Hemostatic Status of Hemophilia A Patients in Daily Clinical Practice

Angel Bernardo et al.

Summary: Hemophilia A is a rare bleeding disorder treated with FVIII replacement therapy. Laboratory monitoring of FVIII activity is difficult, while thrombin generation test parameters may accurately reflect the hemostatic status of patients. Combining thrombin generation test parameters with severity of symptoms and F8 mutation type can improve prognostic capacity.

JOURNAL OF CLINICAL MEDICINE (2022)

Article Anesthesiology

A prospective observational study of the rapid detection of clinically-relevant plasma direct oral anticoagulant levels following acute traumatic injury

D. Oberladstaetter et al.

Summary: In this study, novel viscoelastic tests were used to assess drug levels in trauma patients. Strong correlations were found between clotting times and plasma drug concentrations, with high sensitivity and specificity values for clinically-relevant cut-off values.

ANAESTHESIA (2021)

Article Cardiac & Cardiovascular Systems

Automated Thrombin Generation Assay for Rivaroxaban, Apixaban, and Edoxaban Measurements

Tamana Meihandoest et al.

Summary: The study found weak correlation between thrombin generation measurements and DOAC drug concentrations, and clinically relevant drug levels were not predicted correctly.

FRONTIERS IN CARDIOVASCULAR MEDICINE (2021)

Article Anesthesiology

Successful Antithrombin Administration in Andexanet Alfa-Associated Heparin Resistance

Heleen J. C. L. Apostel et al.

JOURNAL OF CARDIOTHORACIC AND VASCULAR ANESTHESIA (2021)

Editorial Material Anesthesiology

Andexanet Alfa-Induced Heparin Resistance: When Anticoagulation Really Remains Reversed

Gabor Erdoes et al.

JOURNAL OF CARDIOTHORACIC AND VASCULAR ANESTHESIA (2021)

Article Hematology

Restart of Anticoagulant Therapy and Risk of Thrombosis, Rebleeding, and Death after Factor Xa Inhibitor Reversal in Major Bleeding Patients

Truman J. Milling et al.

Summary: This study analyzes the relationship between restarting oral anticoagulation after major bleeding and thrombosis, rebleeding, and death. The results suggest that restarting anticoagulation may reduce the risk of thrombotic events but increase the risk of rebleeding. There is modest evidence of net benefit for restarting anticoagulants in these patients.

THROMBOSIS AND HAEMOSTASIS (2021)

Review Hematology

2021 Update of the International Council for Standardization in Haematology Recommendations for Laboratory Measurement of Direct Oral Anticoagulants

Jonathan Douxfils et al.

Summary: The ICSH published guidance on measuring DOACs in 2018, and significant changes have occurred since then, including the approval of a new DOAC and a specific DOAC reversal agent. Additional research is needed in areas such as patient populations and point-of-care testing.

THROMBOSIS AND HAEMOSTASIS (2021)

Article Medicine, General & Internal

Impact of Idarucizumab and Andexanet Alfa on DOAC Plasma Concentration and ClotPro(R) Clotting Time: An Ex Vivo Spiking Study in A Cohort of Trauma Patients

Daniel Oberladstatter et al.

Summary: Specific antagonists have been developed for the reversal of direct oral anticoagulants and were found to significantly impact the plasma concentration and clotting time of dabigatran and factor Xa inhibitors.

JOURNAL OF CLINICAL MEDICINE (2021)

Article Hematology

Direct oral anticoagulant plasma levels and thrombin generation on ST Genesia system

Christian Pfrepper et al.

RESEARCH AND PRACTICE IN THROMBOSIS AND HAEMOSTASIS (2020)

Review Hematology

Detecting Anti-IIa and Anti-Xa Direct Oral Anticoagulant (DOAC) Agents in Urine using a DOAC Dipstick

Job Harenberg et al.

SEMINARS IN THROMBOSIS AND HEMOSTASIS (2019)

Article Pharmacology & Pharmacy

Andexanet Alfa: First Global Approval

Young-A Heo

Review Pharmacology & Pharmacy

Coagulation Factor Xa (Recombinant), Inactivated-zhzo (Andexanet Alfa)

Danial E. Baker

HOSPITAL PHARMACY (2018)

Article Hematology

Preclinical safety and efficacy of andexanet alfa in animal models

G. Lu et al.

JOURNAL OF THROMBOSIS AND HAEMOSTASIS (2017)

Article Medicine, General & Internal

Andexanet Alfa for Acute Major Bleeding Associated with Factor Xa Inhibitors

Stuart J. Connolly et al.

NEW ENGLAND JOURNAL OF MEDICINE (2016)

Article Medicine, General & Internal

Andexanet Alfa for the Reversal of Factor Xa Inhibitor Activity

Deborah M. Siegal et al.

NEW ENGLAND JOURNAL OF MEDICINE (2015)

Article Hematology

How the Direct Oral Anticoagulant Apixaban Affects Thrombin Generation Parameters

Armando Tripodi et al.

THROMBOSIS RESEARCH (2015)

Editorial Material Cardiac & Cardiovascular Systems

The Real Decoy An Antidote for Factor Xa-Directed Anticoagulants

Calvin H. Yeh et al.

CIRCULATION RESEARCH (2013)

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Recollections on thrombin generation

H. C. HEMKER

JOURNAL OF THROMBOSIS AND HAEMOSTASIS (2009)