Volume 11 Supplement 2
Reversal of oral anticoagulation with prothrombin complex concentrate (Octaplex)
© BioMed Central Ltd. 2007
Published: 22 March 2007
Oral anticoagulant therapy with vitamin K antagonists may need to be rapidly reversed if acute bleeding occurs or surgical intervention is required. This can most effectively be achieved by administering prothrombin complex concentrates (PCCs), which correct the INR more quickly than fresh frozen plasma without the problem of volume overload. Octaplex, a virus-inactivated PCC containing balanced potencies of coagulation factors and the regulating proteins C and S, was developed with the intention of making a rapid contribution to coagulation whilst limiting the risk of thrombosis.
The objective of this prospective, open-label study was to demonstrate that Octaplex, when individually dosed, efficiently corrects the INR within 1 hour post infusion. Sixty patients were included, 56 of them evaluable in terms of efficacy.
The median total dose was 41.1 IU/kg body weight (range 15.3–83.3 IU/kg body weight). In total the mean infusion rate was 6.42 ml/minute for the first infusion. In about one-third of the patients an average infusion rate of ≥8 ml/minute was used. The median INR decreased from 2.8 (1.5–9.5) to 1.1 (1.0–1.9) after 10 minutes and remained at that level at measurements 30 and 60 minutes after infusion. There was a rapid increase in coagulation factor activity within the first 10 minutes as well. This activity remained stably elevated for at least 4–6 hours, confirming the INR results. Of 56 patients evaluable for efficacy, for 51 (91%) the geometric mean of postinfusion values was equal to or less than the predetermined target INR. Overall haemostatic efficacy was assessed as 'excellent' by investigators in all 56 patients. Three of the 60 patients had minor adverse drug reactions possibly related to Octaplex. No evidence of thrombotic side effects was observed.
Octaplex corrects quickly, effectively and safely the INR to a predetermined level in patients with vitamin K antagonist-related deficiency of prothrombin complex coagulation factors.