Prothrombin complex concentrate for emergency surgery in patients on oral Xa-inhibitors

Abstract

BackgroundIt is uncertain whether prothrombin complex concentrate (PCC) improves hemostasis in patients on treatment with oral factor Xa-inhibitors (XaI) who require emergency surgery. ObjectivesTo evaluate whether, in patients with therapeutic levels of oral XaI, preoperative PCC prevents excessive bleeding during and after emergency surgery and is not associated with thrombotic complications. MethodsWe conducted a prospective cohort study wherein a fixed 2000 IU dose of 4-factor PCC was given to patients taking oral XaI with plasma XaI levels of at least 75 ng/mL before the emergency surgery with an expected blood loss of at least 50 mL. Patients were followed for 30 days. The primary efficacy outcome was the incidence of normal or mildly abnormal surgical hemostasis, as assessed by the surgeon; primary safety outcome was the incidence of thromboembolic events within 7 days. ResultsWe included 20 patients, 50% were female, on apixaban (75%) or rivaroxaban (25%) with median XaI level of 128 ng/mL (range 77-497). The median duration of surgery was 2h 42 min (15 min to 8h 17 min). Normal or mildly abnormal hemostasis was observed in 16 patients (80%), 2 patients had moderately abnormal and 2 had severely abnormal hemostasis, 1 each of those was considered due to local or technical factors. There were 4 deaths (20%) secondary to underlying disease and 1 incidental pulmonary embolism in a patient with cancer. ConclusionA fixed dose PCC appears to control hemostasis in patients with therapeutic plasma levels of apixaban or rivaroxaban requiring emergency surgery.