A Retrospective Evaluation of Safety Outcomes of Four-Factor Prothrombin Complex Concentrate & Tranexamic Acid Versus Four-Factor Prothrombin Complex Concentrate Alone in Patients Requiring Emergent Anticoagulation Reversal

Utilizing four-factor prothrombin complex concentrate (4F-PCC) and tranexamic acid (TXA) concomitantly may theoretically elevate the risk of thromboembolism compared to either agent alone. Certain clinical situations arise where a patient may be a candidate for both TXA and 4F-PCC, such as trauma with major hemorrhage requiring anticoagulation reversal. In the absence of published literature, it is largely unknown whether coadministration of both agents increases the risk of thromboembolic events. The objective of this study was to explore safety outcomes of utilizing both 4F-PCC and TXA concomitantly in patients requiring emergent anticoagulation reversal due to a major hemorrhage. A single-center, retrospective chart review was conducted in adult patients who received 4F-PCC + TXA or 4F-PCC alone for emergent anticoagulation reversal of warfarin, apixaban, or rivaroxaban. The primary endpoint was the occurrence of thromboembolic events. The secondary endpoint was all-cause in-hospital mortality. Of the 110 patients included, 74 received 4F-PCC only and 36 patients received both 4F-PCC and TXA. The occurrence of thromboembolism was significantly higher in the 4F-PCC + TXA group compared to the 4F-PCC group (16.7% vs 2.7%; P = 0.0144). The incidence of all-cause in-hospital mortality was similar between groups [19.4% (4F-PCC + TXA) vs 10.8% (4F-PCC); P = 0.346]. The utilization of both 4F-PCC and TXA for patients with major hemorrhage requiring emergent anticoagulation reversal was associated with a significantly higher risk of thromboembolism than 4F-PCC alone. Clinicians should use caution when utilizing 4F-PCC and TXA concomitantly.