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

Completed · Phase 2 · Has a placebo group

Conditions studied: Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass

In brief

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.

Key facts

Study ID

NCT00914589

Run by

Novo Nordisk A/S

People needed

479

Starts

2009-07-01

Expected to finish

2011-02-01

Last updated by the study team

2017-03-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Atlanta, Georgia, United States
• Novo Nordisk Investigational Site — Durham, North Carolina, United States
• Novo Nordisk Investigational Site — Portland, Oregon, United States
• Novo Nordisk Investigational Site — Allentown, Pennsylvania, United States
• Novo Nordisk Investigational Site — Philadelphia, Pennsylvania, United States
• Novo Nordisk Investigational Site — Providence, Rhode Island, United States
• Novo Nordisk Investigational Site — Houston, Texas, United States
• Novo Nordisk Investigational Site — Toronto, Ontario, Canada
• Novo Nordisk Investigational Site — Montreal, Canada
• Novo Nordisk Investigational Site — Ottawa, Canada
• Novo Nordisk Investigational Site — Québec, Canada
• Novo Nordisk Investigational Site — Toronto, Canada
• Novo Nordisk Investigational Site — København Ø, Denmark
• Novo Nordisk Investigational Site — Berlin, Germany
• Novo Nordisk Investigational Site — Frankfurt am Main, Germany
• Novo Nordisk Investigational Site — Ludwigshafen, Germany
• Novo Nordisk Investigational Site — München, Germany
• Novo Nordisk Investigational Site — Petah Tikva, Israel
• Novo Nordisk Investigational Site — Ramat Gan, Israel
• Novo Nordisk Investigational Site — Bologna, Italy
• Novo Nordisk Investigational Site — Milan, Italy
• Novo Nordisk Investigational Site — San Donato Milanese (MI), Italy
• Novo Nordisk Investigational Site — Numakunai, Japan
• Novo Nordisk Investigational Site — Osaka, Japan
• Novo Nordisk Investigational Site — Tokyo, Japan

Full record on ClinicalTrials.gov

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