Octaplex is a new prothrombin complex concentrate that is indicated for treatment or perioperative prophylaxis of bleeding in patients with deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin K antagonists or by liver failure, when rapid correction of bleeding is required. The study was conducted to demonstrate both prevention of bleeding and achievement of haemostasis in acute bleeding and to obtain further information about the safety of administration of Octaplex.
One hundred and one patients were included in this observational study with determination of the INR as part of routine clinical management. The endpoint of this study was perioperative prophylaxis of bleeding or successful treatment of acute bleeding according to clinical signs.
The total dose administered per patient varied from 5.6 to 63.5 IU/kg bodyweight with a median dose of 20.4 IU/kg bodyweight. The median infusion rate was 3 ml/minute; in some cases up to 10 ml/minute were administered without any adverse reactions. The administration of Octaplex reduced the INR on average from 2.3 to 1.5. Infusion of 25 IU Octaplex per kg body weight resulted in an average decrease of about 1.2 in INR. A subgroup analysis of those patients with a postinfusion measurement within 1 hour after application of Octaplex showed a fast onset of action. The investigators evaluated the overall efficacy of Octaplex in 84.2% of cases as 'very good' and in 14.9% of cases as 'moderate'. No adverse drug reactions or interactions were reported.
Octaplex is effective in perioperative prophylaxis of bleeding in patients with a coagulation deficit caused by treatment with vitamin K antagonists. Octaplex is also effective in treatment of acute bleeding. Octaplex was well tolerated, with no adverse reactions being reported during the study.