Multi-national Study Investigating the Effect and Safety of rFXIII on Transfusion Needs in Patients Undergoing Heart Surgery

Phase 2

Completed

Conditions: Cardiac Surgery Requiring Cardiopulmonary Bypass
Acquired Bleeding Disorder

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.

Recruitment & Eligibility

Inclusion Criteria

- Planned coronary artery bypass grafting (CABG) or CABG plus single heart valve replacement/repair or planned replacement/repair of a single heart valve

Exclusion Criteria

Known intolerance to protamine
Known or suspected allergy to the used antifibrinolytic agent
Refusal to receive blood or blood product
Planned surgery including the aortic arch and/or descending aorta
Planned surgery including any implantable ventricular assist device
Adult congenital heart diseases
Two or more previous cardiac surgery procedures
Any known autoimmune diseases: Collagen vascular disease (Systemic lupus erythematosus, Rheumatoid arthritis, Sjögrens syndrome) - Endocrine: hyperthyroidism (Graves disease), adrenal insufficiency, Hashimoto's thyroiditis - Neurologic: Multiple sclerosis, myasthenia gravis - Skin: pemphigous vulgaris Hematologic: Pernicious anaemia, Autoimmune haemolytic anaemia - Vasculitis - Primary or secondary antiphospholipid syndrome
Weight above 140 kg

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
FXIII17.5IU/Kg	catridecacog	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.
FXIII35IU/Kg	catridecacog	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Avoiding Any Allogeneic Transfusions for Seven Days Post-operative or Until Discharge, Whichever Came First	measured ongoing from dosing until day 7 or discharge, whichever came first	Proportion of patients avoiding blood products given via allogeneic transfusion. Blood products were defined as any of the following: RBC, platelets, FFP, fibrinogen concentrate and clotting factor(s) concentrate, including cryoprecipitate.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects With Thromboembolic Events	measured from screening until 5-7 weeks post Trial Drug Administration	Percentage of subjects with thromboembolic events (AMI, cerebrovascular thromboembolic event, peripheral artery occlusion, DVT, pulmonary embolism) until end of trial
Percentage of Subjects With rFXIII Antibody Reaction	measured from screening until 5-7 weeks post Trial Drug Administration	Immunogenicity as number of subjects who manifested FXIII antibody reaction until end of trial. The percentage may be derived from the number of subjects treated with rFXIII with available antibody measurement at visit 8.
Percentage of Subjects With Critical Adverse Events	measured from screening until 5-7 weeks post Trial Drug Administration	Percentage of subjects with critical adverse events (thromboembolic events (AMI, cerebrovascular thromboembolic event, peripheral artery occlusion, DVT, pulmonary embolism), renal dysfunction, re-operation and death) until end of trial
Percentage of Subjects With Serious Adverse Events	measured from screening until 5-7 weeks post Trial Drug Administration	Percentage of subjects with serious adverse events until end of trial.