Activated prothrombin complex concentrate for the prevention of dabigatran‐ associated bleeding

The use of prothrombin complex concentrates (PCC), activated PCC (aPCC e.g. factor eight inhibitor bypassing activity [FEIBA, Baxter, Vienna, Austria]) or recombinant activated factor VII (rVIIa; NovoSeven®, Novo Nordisk, Bagsvaerd, Denmark) to ‘reverse’ anticoagulation in patients bleeding on oral direct inhibitors (ODIs) has little theoretical basis. rFVIIa activates coagulation above the point where the ODIs act. PCCs are not replacing a missing factor but might provide a large amount of the substrate prothrombin, so increasing thrombin generation. FEIBA could be combining the effects of FVIIa and PCC (Marlu et al, 2012) but alternatively, an activated factor X (FXa):prothrombin complex may be the main active component (Turecek et al, 2004). We read with interest the correspondence by Schulman and colleagues (Schulman et al, 2014) in which they described the use of FEIBA in dabigatran-associated bleeding. We would like to report a case where FEIBA prevented bleeding in a patient with high levels of dabigatran who needed a high risk procedure. An 80-year-old patient with septic shock and acute renal failure required urgent percutaneous trans-hepatic drainage of a gallbladder empyema. He had a history of atrial fibrillation (CHADS-VASC score 6 - hypertension, type 2 diabetes, previous stroke and peripheral vascular disease) for which he was on dabigatran 110 mg bd. His last dose of dabigatran was 30 h previously. His creatinine was 430 μmol/l with an estimated creatinine clearance of 17 ml/min. The activated partial thromboplastin time was 50·4 s (normal 26–36), thrombin time 212 s and the dabigatran level, measured with a dilute thrombin time assay (Hemoclot®, Hyphen Biomed, Neurillesur, Oise, France), was 200 μg/l. He was assessed as needing urgent drainage of the gall-bladder empyema and immediately prior to trans-hepatic ultrasound-guided drainage, he received 40 units/kg of FEIBA. There were no bleeding complications and the patient's clinical state dramatically improved. We conclude that, as well as being useful for critical bleeding in patients on dabigatran, FEIBA may allow an emergency procedure with substantial bleeding risk to be undertaken despite significant therapeutic levels of dabigatran.