Efficacy and safety of a prothrombin complex concentrate (Octaplex (R)) for rapid reversal of oral anticoagulation

Bleeding is the most serious adverse event of oral anticoagulants and is a major cause of morbidity and mortality in such patients. Rapid reversal of anticoagulation in bleeding patients or prior to urgent surgery is mandatory. The therapeutic options in these situations include administration of fresh frozen plasma (FFP), and recently of prothrombin complex concentrates (PCCs). However, viral safety and thrombogenicity of PCCs remain issues of concern. In the present study, we administered Octaplex(R), a new solvent/detergent (S/D) treated and nanofiltered PCC, to excessively anticoagulated bleeding patients or to anticoagulated patients facing urgent surgery. Ten excessively anticoagulated patients with major bleeding and 10 anticoagulated patients awaiting surgery (median age 72.5 (43-83) years, 9 females) received a median dose of 26.1 IU/kg body weight (BW) of Octaptex(R) for reversal of anticoagutation. Response to Octaplex(R) was rapid with decline of INR within 10 min after Octaptex(R) administration (from 6.1 +/- 2. to 1.5 +/- 0.3). Clinical response was graded as good in most patients (85%) and as moderate in the rest. Octaplex(R) administration was uneventful in all patients. Following Octaptex(R) administration, a small increase in F1 + 2 levels was observed in bleeding patients, whereas D-dimer level did not change significantly. We conclude that Octaplex(R) is effective and safe in situations where rapid reversal of anticoagulation is needed. (C) 2004 Elsevier Ltd. All rights reserved.