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

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Cardiac Surgery Requiring Cardiopulmonary Bypass; Acquired Bleeding Disorder

Treatments: Drug: catridecacog; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00914589

NN1810-3540

2008-006324-62 (EudraCT Number)

JapicCTI-101078 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 479 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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479 participants in 3 patient groups, including a placebo group

FXIII17.5IU/Kg

Experimental group

Description:

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.

Treatment:

Drug: catridecacog

Drug: catridecacog

FXIII35IU/Kg

Experimental group

Description:

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.

Treatment:

Drug: catridecacog

Drug: catridecacog

Placebo

Placebo Comparator group

Description:

Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.

Treatment:

Drug: placebo