Conditions: Acquired Bleeding Disorder Cardiac Surgery Requiring Cardiopulmonary Bypass
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 479
Healthy volunteers: no

Brief summary:
This trial is conducted in Canada, Asia, Europe and USA. The aim of this clinical trial is to investigate the effect and safety of rFXIII on transfusion needs in patients undergoing heart surgery.

Detailed description:

Arms:
arm 1: Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute. arm 2: Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute. arm 3: Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.

Interventions: intervention 1: catridecacog intervention 2: catridecacog intervention 3: placebo
Intervention descriptions: intervention 1: Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute intervention 2: Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute intervention 3: Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute

Protocol document: