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All About Bleeding

F1000 Medical Research Posters - Acquired Bleeding

The following medical research posters about Anticoagulant Reversal are provided as resources and can be found on F1000.com.

Anticoagulant Reversal

  • Four-factor prothrombin complex concentrate (4F-PCC) reverses bleeding associated with the new direct oral anticoagulants (NOACs) dabigatran, rivaroxaban, edoxaban and apixaban in a rabbit model
    Eva Herzog, Franz Kaspereit, Wilfried Krege, Jochen Mueller-Cohrs, Baerbel Doerr, Peter Niebl, Gerhard Dickneite. F1000Posters 2015 (poster) [English]   Main Conclusion: In this rabbit model of acute haemorrhage 4F-PCC, administered at a clinically relevant dose range, showed potential for reversing NOAC-associated bleeding for all NOACs tested, including direct FIIa inhibitor dabigatran, and FXa inhibitors edoxaban, rivaroxaban and apixaban. These data suggest that 4F-PCC may be an option for the urgent reversal of the anticoagulant effect of NOACs. Further clinical data in human patients are required to confirm these results. Summary

  • Four-factor prothrombin complex concentrate (4F- PCC) is superior to three-factor prothrombin concentrate (3F-PCC) for reversal of coumarin anticoagulation
    Eva Herzog, Franz Kaspereit, Wilfried Krege, Peter Niebl, Stefan Schulte, Gerhard Dickneite. F1000Posters 2015 (poster) [English]   Main Conclusion: Direct comparison of 4F-PCC and 3F-PCC for the reversal of VKA anticoagulation in a rat model of acute bleeding suggests that replenishment of all vitamin K-dependent coagulation factors including factor VII as achieved using a 4F-PCC may result in superior efficacy compared to the use of 3F-PCC. Summary

  • Four-factor prothrombin complex concentrate (4F-PCC) is superior to three-factor prothrombin concentrate (3F-PCC) for reversal of coumarin anticoagulation
    Eva Herzog, Franz Kaspereit, Wilfried Krege, Peter Niebl, Stefan Schulte, Gerhard Dickneite F1000Posters 2015, 6: 259 (poster) [English]   Main Conclusion: In conclusion, this first direct comparison of 4F-PCC and 3F-PCCs for the reversal of VKA anticoagulation in a rat model of acute bleeding suggests that replenishment of all vitamin K-dependent coagulation factors including factor VII as achieved using a 4F-PCC may result in superior efficacy compared to the use of 3F-PCCs. Summary

  • Four-factor prothrombin complex concentrate (4F-PCC) effectively reverses rivaroxaban induced bleeding in a rabbit model of acute bleeding
    Eva Herzog, Jochen Muller-Cohrs, Franz Kaspereit, et al. F1000Posters 2015, 6: 260 (poster) [English]   Main conclusion: In summary, in a rabbit model of acute bleeding, 4F-PCC was able to effectively reduce bleeding to control levels following rivaroxaban 150 μg/kg and 300 μg/kg administrations. The 4F-PCC mediated bleeding reversal correlated best with the in vitro endpoints thrombin generation and whole blood clotting time. Summary

  • 4F-PCC (Beriplex®; P/N) is superior to 3F-PCC for reversal of coumarin anticoagulation
    Eva Herzog, Franz Kaspereit, Wilfried Krege, Peter Niebl, Stefan Schulte, Gerhard Dickneite F1000Posters 2015, 6: 261 (poster) [English]   Main conclusion: This first direct comparison of 4F-PCC and 3F-PCCs for the reversal of VKA anticoagulation in a rat model of acute bleeding suggests that replenishment of all four vitamin K-dependent coagulation factors including factor VII as achieved using a 4F-PCC may result in superior efficacy compared to the use of 3F-PCCs. Summary

  • 4F-PCC (Beriplex® P/N) mediated reversal of apixaban induced bleeding in a rabbit model
    Eva Herzog, Franz Kaspereit, Wilfried Krege, et al. F1000Posters 2015, 6: 262 (poster) [English]   Main conclusion: Treatment with 4F-PCC resulted in a statistically significant reversal in apixaban induced bleeding time (all doses) and volume (doses ≥12.5 IU/kg). Summary

  • Increased risk of volume overload with plasma compared to 4-factor prothrombin complex concentrate (4F-PCC) for the emergency reversal of vitamin K antagonist (VKA) therapy
    Majed A Refaai, Joshua N Goldstein, Martin L Lee, Truman J Milling Jr, Ravi Sarode F1000Posters 2014, 5: 1147 (poster) [English]   Main conclusion: 388 patients (4F-PCC, n=191; plasma, n=197) were enrolled. Volume overload occurred in 25 (12.7%) plasma-treated patients and 9 (4.7%) 4F-PCC-treated patients. While race was a risk factor for volume overload in univariate analyses, this effect was non-significant after controlling for medical comorbidities. Based on logistic regression modeling, plasma vs 4F-PCC use, history of CHF and history of renal disease were the only independent predictors of volume overload. These results suggest that caution should be exercised when using plasma for rapid VKA reversal, particularly in patients with CHF and/or renal disease. Summary

  • Randomized Phase IIIb study of rapid vitamin K antagonist reversal in patients requiring an urgent surgical procedure: four-factor prothrombin complex concentrate is superior to plasma
    M Refaai, J Goldstein, T Milling Jr., et al. F1000Posters 2014, 5: 56 (poster) [English]   Main conclusion: For both hemostatic efficacy and rapid INR reduction, 4F-PCC was shown to be superior to plasma. Furthermore, the safety profile of 4F-PCC was favorable and was well tolerated in this population, as compared to plasma. In particular, fluid overload events were more frequent in the plasma group compared with the 4F-PCC group. Therefore, for rapid VKA reversal in patients requiring an urgent surgical procedure, 4F-PCC was found to be an effective alternative to plasma. Summary

  • Pre-clinical safety aspects on the use of Beriplex® P/N for reversal of Dabigatran anticoagulation
    E Herzog, F Kaspereit, W Krege, Jv Ryn, G Dickneite, I Pragst F1000Posters 2013, 4: 182 (poster)   Main conclusion: Overall, the study confirmed the effective reversal of dabigatran-induced bleeding by the PCC Beriplex® P/N while maintaining dabigatran’s anticoagulative effects. The potential procoagulant effects of high dose PCC could be markedly reduced or even inhibited in the presence of dabigatran. Summary

  • Safety of a 4-factor prothrombin complex concentrate (4F-PCC) versus plasma for vitamin K antagonist reversal: an integrated analysis of phase III clinical trial data
    TJ Milling, MA Refaai, R Sarode, A Mangione, BL Durn, JN Goldstein F1000Posters 2013, 4: 103 (poster)   Main conclusion: Overall, this 4-factor PCC was safe and well-tolerated, with a safety profile at least as good as plasma, for subjects receiving vitamin K antagonists (VKAs) and who require urgent replacement of vitamin K-dependent clotting factors. Summary

  • Integrated safety analysis of a 4-factor prothrombin complex concentrate versus plasma in Phase III clinical trials
    R Sarode, TJ Milling, MA Refaai, A Mangione, BL Durn, JN Goldstein F1000Posters 2012, 3: 555 (poster)   Main conclusion: Overall, this 4-factor PCC was safe and well-tolerated, with a safety profile at least as good as plasma, for subjects receiving vitamin K antagonists (VKAs) and who require urgent replacement of vitamin K-dependent clotting factors. Summary

  • Perceptions about rapid warfarin reversal with fresh frozen plasma to reduce the INR: A novel survey methodology
    J Petrozzino, J Hoesche, C Jones, JH Levy F1000Posters 2011, 2: 776 (poster)   Main conclusion: Healthcare providers may have inaccurate perceptions of the time required for initial International Normalized Ratio (INR) normalization with fresh-frozen plasma (FFP). Volume of FFP and co-administration of factor concentrates may influence these perceptions. Subsequent-to-first FFP dose infusion time accounts for ~50% of perceived INR normalization time. Summary

  • Beriplex P/N reverses bleeding in an acute renal injury model after dabigatran overdose in rabbits
    I Pragst, B Dörr, F Kaspereit, W Krege, S Zeitler, J van Ryn F1000Posters 2012, 3: 167 (poster)   Main conclusion: Beriplex® P/N inhibits bleeding induced with supratherapeutic doses of dabigatran in a rapid, dose-dependent manner. The highest dose of 50 U/kg Beriplex P/N reduced bleeding close to baseline values. This hemostatic effect could be observed despite lack of normalization of either the thrombin time, or aPTT values measured ex vivo. Thus, Beriplex P/N could potentially be used as an antidote for the direct oral thrombin inhibitor dabigatran in case of emergency bleeding complications. Summary

Last Updated: 11/13/2015 12:18 PM
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