Evaluating protocol adherence during anti-inhibitor coagulant complex administration for reversal of Xa inhibitors for life-threatening bleeding

Introduction: Anti-inhibitor coagulant complex (FEIBA®) contains the coagulation factors II, VIIa, IX, and X. Factor Xa inhibitors currently have no FDA approved reversal agent. Ex vivo studies utilizing human blood samples demonstrated that FEIBA® might reverse the anticoagulant effect induced by these agents. FEIBA’s impact on clinically significant reversal is unknown at this time as no randomized, controlled trials in patients with life-threatening bleeding have been conducted. The purpose of our study is to examine the FEIBA® protocol at Allegheny General Hospital.

Objectives:

Primary: Adherence to protocol for FEIBA administration

Secondary:

• Incidence of thromboembolic events within 7 days
• Clinical parameter of FEIBA administration to reverse the anticoagulant effect of FXa inhibitors
• Median change from baseline  in coagulation assays after FEIBA®
• In-hospital mortality
• Effect of clinical pharmacy specialist involvement on adherence

Study Design: Single-center retrospective cohort

Methods: Patients at least 18 years of age with life-threatening bleeding while taking an oral factor Xa inhibitor were included. IRB exemption was obtained. Medication administration and outcomes were evaluated using CPOE and the medical chart.

Results:

• 52% of patients were non-adherent to protocol; 64% of which were due to unknown timing of the last dose of anticoagulant and aPTT < 34 seconds
• 1 thromboembolic event occurred within 7 days of FEIBA® administration
• More pharmacy specialist involvement was seen in adherent versus non-adherent patients
• Median changes in coagulation assays were greater in adherent versus non-adherent patients

Conclusions:

• Our protocol dose of 20 units/kg appears to be safe given only one thromboembolic event occurred within 7 days of FEIBA® administration
• Based on clinical parameters of hemoglobin, GCS score, surgical procedures performed, and use of additional products, FEIBA® appears to have prevented further bleeding in our sample of patients
• Limitations include difficulty determining the time of the last dose of FXa inhibitor and relying on retrospective documentation