AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca 
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  • ||||||||||  AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
    Enrollment closed, Trial completion date, Trial primary completion date:  Trial of Andexanet Alfa in ICrH Patients Receiving an Oral FXa Inhibitor (clinicaltrials.gov) -  Aug 2, 2023   
    P4,  N=1200, Active, not recruiting, 
    The lack of a control group limits the strength of the conclusions that can be drawn from this study. Recruiting --> Active, not recruiting | Trial completion date: Jul 2024 --> Aug 2023 | Trial primary completion date: May 2024 --> May 2023
  • ||||||||||  AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
    Journal:  Recommendations for the use of andexanet alfa in the management of bleeding in patients on oral factor Xa inhibitors in Switzerland. (Pubmed Central) -  Jul 31, 2023   
    The present recommendations on the use of andexanet alfa in the management of bleeding in patients on factor Xa inhibitors in Switzerland were developed by a group of Swiss experts from the Working Party Hemostasis of the Swiss Society of Hematology. These recommendations aim to provide support to clinicians in their decision-making in the management of patients with major bleeding receiving factor Xa inhibitors.
  • ||||||||||  Octaplex (human prothrombin complex concentrate) / Octapharma, Pfizer, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
    Journal, Surgery:  Effect of PCC on Thrombin Generation among Patients on Factor Xa Inhibitors with Major Bleeding or Needing Urgent Surgery (GAUGE): Design and Rationale. (Pubmed Central) -  Jul 27, 2023   
    Clinicians have variable national and regional access to specific FXaI reversal agents such as andexanet alfa...Objective ?GAUGE is a prospective observational study designed to measure the effects of four-factor PCC administration (Octaplex) on TGA parameters among patients with FXaI-associated bleeding or needing urgent surgery...Conclusion ?Development of a viable and universally accessible FXaI bleed management strategy is crucial. GAUGE will provide in vivo data on the effects of PCC among patients with FXaI-associated bleeding.
  • ||||||||||  AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
    Test Of Residual Anticoagulation After Neutralization By Andexanet-alpha: Usefulness Of Dielectric Coagulometer (South: Hall F) -  Jul 20, 2023 - Abstract #ASA2023ASA_279;    
    Our newly developed test in DBCM showed usefulness in the evaluation of neutralization of factor-Xa inhibitor by andexanet-alpha. Although neutralization induced by andexanet-alpha resulted in slight prolongation of CT compared with the samples after sufficient cessation of medication, small difference prevents underestimation of the effect of neutralization induced by andexanet-alpha.
  • ||||||||||  Praxbind (idarucizumab) / Boehringer Ingelheim, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
    Journal:  Bleeding management in patients with direct oral anticoagulants. (Pubmed Central) -  Jul 3, 2023   
    To determinate, if DOAC reversal is indicated or not, time from last intake, anti-Xa/dTT values or results from POC tests can be considered. This experts' opinion provides a feasible decision algorithm for clinical practice.
  • ||||||||||  AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
    Clinical, Review, Journal:  Andexanet (Pubmed Central) -  Jun 19, 2023   
    No abstract available Andexanet
  • ||||||||||  AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
    Journal:  Andexanet alfa in acute aortic syndrome: first UK experience. (Pubmed Central) -  Jun 19, 2023   
    Its use was instrumental in securing haemostasis. However, we caution against the administration of Andexanet alfa prior to cardiopulmonary bypass as it can induce heparin resistance and complicate the perioperative monitoring of anticoagulation during CPB.
  • ||||||||||  Praxbind (idarucizumab) / Boehringer Ingelheim, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
    Journal, Adherence:  Adherence to protocols for the use of reversal agents in patients treated with direct oral anticoagulants. (Pubmed Central) -  Jun 12, 2023   
    For andexanet alfa, adherence to the hospital bleeding protocol was "moderate" (67%), with a lack of indication being the only reason for non-adherence...Missing lab data on dabigatran plasma concentration before reversal was the main reason for "low" adherence (26%) in idarucizumab...In case of reversal for bleeding under DOAC, overall adherence to the protocol was "moderate"; however, in patients needing an urgent procedure, it was "low." The major reasons for non-adherence were underdosing, off-label use, and a lack of specific lab testing. The results of this study can assist in improving the implementation of hospital protocols.
  • ||||||||||  Praxbind (idarucizumab) / Boehringer Ingelheim, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
    Journal:  Reversal of Oral Anticoagulants: A Survey of Contemporary Practice Trends (ReACT). (Pubmed Central) -  Jun 9, 2023   
    Andexanet alfa was only reported on formulary at 35.9% of institutions...Our findings revealed that guideline recommendations for reversal of warfarin and factor Xa and IIa inhibitors are not followed by a majority of institutions. Studies are needed to investigate strategies to overcome barriers for implementing and following guideline recommendations.
  • ||||||||||  AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
    Journal, Surgery:  Safety of Andexanet Alfa Use in Cardiac Surgery. (Pubmed Central) -  Jun 5, 2023   
    Studies are needed to investigate strategies to overcome barriers for implementing and following guideline recommendations. No abstract available
  • ||||||||||  Savaysa (edoxaban) / Daiichi Sankyo, Praxbind (idarucizumab) / Boehringer Ingelheim, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
    Journal:  Reversal agents for current and forthcoming direct oral anticoagulants. (Pubmed Central) -  May 22, 2023   
    Reversal can be effected with specific agents, such as idarucizumab for dabigatran and andexanet alfa for apixaban, edoxaban, and rivaroxaban, or with non-specific agents, such as prothrombin complex concentrates, activated prothrombin complex concentrate, and recombinant activated factor VII. This paper (i) provides an update on when and how to reverse the DOACs, (ii) describes new reversal agents under development, and (iii) provides a strategic framework for the reversal of the factor XI inhibitors currently under investigation in phase three clinical trials.
  • ||||||||||  Praxbind (idarucizumab) / Boehringer Ingelheim, AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
    Review, Journal:  The methods for removal of direct oral anticoagulants and heparins to improve the monitoring of hemostasis: a narrative literature review. (Pubmed Central) -  May 20, 2023   
    The necessity to remove heparins is also arising as heparin contamination from central venous catheter or therapy with heparin disturbs the appropriate hemostasis assessment. Heparinase and polybrene are already present in commercial reagents but a fully-effective neutralizer is still a challenge for researchers, thus promising candidates remain in the research phase.
  • ||||||||||  AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
    Journal:  Massive Post-polypectomy Bleeding in a Patient on Apixaban Reversed with Andexanet Alfa. (Pubmed Central) -  May 19, 2023   
    Heparinase and polybrene are already present in commercial reagents but a fully-effective neutralizer is still a challenge for researchers, thus promising candidates remain in the research phase. No abstract available
  • ||||||||||  AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
    Journal:  Final Study Report of Andexanet Alfa for Major Bleeding With Factor Xa Inhibitors. (Pubmed Central) -  Mar 29, 2023   
    P3
    When emergency reversal of DOAC-related anticoagulation is required, specific DOAC reversal agents are recommended, including idarucizumab for dabigatran reversal and andexanet In patients with major bleeding associated with the use of FXa inhibitors, treatment with andexanet alfa reduced anti-FXa activity and was associated with good or excellent hemostatic efficacy in 80% of patients.
  • ||||||||||  AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
    Journal:  Andexanet alfa vs. four-factor prothrombin complex concentrate. (Pubmed Central) -  Mar 25, 2023   
    In patients with major bleeding associated with the use of FXa inhibitors, treatment with andexanet alfa reduced anti-FXa activity and was associated with good or excellent hemostatic efficacy in 80% of patients. No abstract available
  • ||||||||||  Review, Journal:  Practical Guide for Anticoagulant and Antiplatelet Reversal in Clinical Practice. (Pubmed Central) -  Feb 24, 2023   
    DOACs are associated with lower rates of fatal, life-threatening, and significant bleeding risks compared to those of warfarin...Andexanet alfa and idarucizumab are specific reversal agents for DOACs and DTIs, respectively...However, there are no specific reversal agents for antiplatelets. This article aims to provide a practical guide for clinicians regarding the reversal of anticoagulants and antiplatelets in clinical practice based on the most recent studies.
  • ||||||||||  AndexXa (coagulation factor Xa (recombinant), inactivated -zhzo) / Daiichi Sankyo, AstraZeneca
    Review, Journal:  How will UK hospitals use andexanet alfa? A review of local protocols. (Pubmed Central) -  Feb 23, 2023   
    This article aims to provide a practical guide for clinicians regarding the reversal of anticoagulants and antiplatelets in clinical practice based on the most recent studies. No abstract available