Status:
COMPLETED
Multi-national Study Investigating the Effect and Safety of rFXIII on Transfusion Needs in Patients Undergoing Heart Surgery
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Acquired Bleeding Disorder
Cardiac Surgery Requiring Cardiopulmonary Bypass
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- \- Planned coronary artery bypass grafting (CABG) or CABG plus single heart valve replacement/repair or planned replacement/repair of a single heart valve
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
479 Patients enrolled
Trial Details
Trial ID
NCT00914589
Start Date
July 1 2009
End Date
February 1 2011
Last Update
March 7 2017
Active Locations (32)
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1
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30322-1059
2
Novo Nordisk Investigational Site
Durham, North Carolina, United States, 27710
3
Novo Nordisk Investigational Site
Portland, Oregon, United States, 97239-3098
4
Novo Nordisk Investigational Site
Allentown, Pennsylvania, United States, 18105