Administration of aPCC as a Prevention of Bleeding After Major Cardiac Surgical Procedures
The possibility of actively preventing severe bleeding after a major cardiac surgical procedure using cardiopulmonary bypass (CPB) by administering a concentrate of activated procoagulant complex seems feasible, although a larger study will be needed to confirm its effect.
Possibilities for Managing Bleeding Associated with CPB
It is known that the transfusion of blood derivatives during cardiac surgical procedures can negatively impact treatment outcomes by increasing the risk of infection, prolonging hospitalization, and increasing mortality. It is therefore very important to look for other ways to reduce the hemorrhagic diathesis associated with procedures involving the establishment of cardiopulmonary bypass.
Current management of bleeding associated with CPB mainly includes the administration of antifibrinolytics. Another option is the use of activated prothrombin complex concentrate (aPCC). In addition to containing coagulation factors present as zymogens, it also contains small amounts of active coagulation factors. If prothrombin complex concentrate (PCC) is used to substitute for missing clotting factors, aPCC can additionally contribute to the targeted initiation of the coagulation process.
aPCC (FEIBA) is approved for the treatment of patients with hemophilia and inhibitor, and it also has the ability to reverse the effects of warfarin, dabigatran, rivaroxaban, or other anticoagulants. Moreover, it has a theoretical advantage over activated FVII during CPB, as it can provide more coagulation factors lost during the procedure. It can thus be used as a therapy for bleeding after CPB. The use of aPCC has been observed to reduce the incidence of complications and decrease the need for transfusions. However, the possibility and effect of early administration of aPCC after the completion of CPB has not yet been studied in a prospective randomized study.
Pilot Study
A group of physicians from Portland, USA, conducted a small randomized double-blind placebo-controlled study using aPCC with the aim of reducing the need for transfusions after CPB. They also evaluated the safety of this treatment.
The study included 12 adult patients undergoing elective major cardiovascular surgery. They were randomized to intraoperative administration of a single dose of aPCC or placebo at the very end of the procedure. Adherence to the protocol was high, with no significant deviations observed, and adverse events did not differ between groups. No differences were observed in post-randomization need for blood product transfusions or in the use of aPCC as open label.
Conclusion
The authors of this pilot study conclude that a larger study will be needed to confirm the efficacy of early administration of aPCC in very high-risk cardiac surgical procedures with the aim of reducing the need for blood product transfusions. This study may confirm whether a prophylactic approach to preventing refractory hemorrhagic diathesis will be effective.
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Source: Sera V. A., Stevens A. E., Song H. K. et al. Factor VIII inhibitor bypass activity (FEIBA) for the reduction of transfusion in cardiac surgery: a randomized, double-blind, placebo-controlled, pilot trial. Pilot Feasibility Stud 2021; 7: 137, doi: 10.1186/s40814-021-00873-5.
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