Acquired Bleeding Disorder Clinical Trial
Official title:
A Multi-Centre, Randomised, Double-Blind, Placebo Controlled Trial on Efficacy and Safety of FXIII Replenishment With Two Different Doses of Recombinant Factor XIII Following Cardiopulmonary Bypass Surgery
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.
Status | Completed |
Enrollment | 479 |
Est. completion date | February 2011 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Novo Nordisk Clinical Trial Call Center | Allentown | Pennsylvania |
United States | Novo Nordisk Clinical Trial Call Center | Atlanta | Georgia |
United States | Novo Nordisk Clinical Trial Call Center | Durham | North Carolina |
United States | Novo Nordisk Clinical Trial Call Center | Houston | Texas |
United States | Novo Nordisk Clinical Trial Call Center | Philadelphia | Pennsylvania |
United States | Novo Nordisk Clinical Trial Call Center | Portland | Oregon |
United States | Novo Nordisk Clinical Trial Call Center | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Novo Nordisk A/S |
United States, Canada, Denmark, Germany, Israel, Italy, Japan, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Subjects Avoiding Any Allogeneic Transfusions for Seven Days Post-operative or Until 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. | measured ongoing from dosing until day 7 or discharge, whichever came first | No |
Secondary | Percentage of Subjects With Thromboembolic Events | Percentage of subjects with thromboembolic events (AMI, cerebrovascular thromboembolic event, peripheral artery occlusion, DVT, pulmonary embolism) until end of trial | measured from screening until 5-7 weeks post Trial Drug Administration | No |
Secondary | Percentage of Subjects With rFXIII Antibody Reaction | 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. | measured from screening until 5-7 weeks post Trial Drug Administration | No |
Secondary | Percentage of Subjects With Critical Adverse Events | 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 | measured from screening until 5-7 weeks post Trial Drug Administration | No |
Secondary | Percentage of Subjects With Serious Adverse Events | Percentage of subjects with serious adverse events until end of trial. | measured from screening until 5-7 weeks post Trial Drug Administration | No |
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