Safety of rFXIII in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass

A Multi-Centre, Randomised, Double-Blind, Placebo Controlled, Dose Escalation Trial on Safety and Pharmacokinetics of Recombinant Factor XIII (rFXIII) in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass

This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the safety of escalating single doses of rFXIII (recombinant factor XIII, catridecacog) administered following first time myocardial revascularization requiring cardiopulmonary bypass (CPB).

Inclusion Criteria:

• Subject is undergoing his/her first myocardial revascularization

Exclusion Criteria:

• Previous participation (randomisation and dosing) in this trial
• Subject has a history of cerebrovascular event (including thrombotic or haemorrhagic stroke or transient ischaemic attack (TIA)) and/or extra-myocardial thromboembolic events, e.g., deep vein thrombosis (DVT) or pulmonary embolus (PE)
• Subject required a pre-operative (within 30 days) transfusion of any blood and/or blood product
• Subject has a current atrial fibrillation or history of atrial fibrillation