Status:
COMPLETED
Safety of rFXIII in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Acquired Bleeding Disorder
Cardiac Surgery Requiring Cardiopulmonary Bypass
Eligibility:
All Genders
35-70 years
Phase:
PHASE1
Brief Summary
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the safety of escalating single doses of rFXIII (recombinant factor XIII, catridecacog) a...
Eligibility Criteria
Inclusion
- Subject is undergoing his/her first myocardial revascularization
Exclusion
- Previous participation (randomisation and dosing) in this trial
- Subject has a history of cerebrovascular event (including thrombotic or haemorrhagic stroke or transient ischaemic attack (TIA)) and/or extra-myocardial thromboembolic events, e.g., deep vein thrombosis (DVT) or pulmonary embolus (PE)
- Subject required a pre-operative (within 30 days) transfusion of any blood and/or blood product
- Subject has a current atrial fibrillation or history of atrial fibrillation
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT02239146
Start Date
October 1 2005
End Date
January 1 2008
Last Update
January 11 2017
Active Locations (24)
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1
Novo Nordisk Investigational Site
Tucson, Arizona, United States, 85714
2
Novo Nordisk Investigational Site
San Francisco, California, United States, 94143
3
Novo Nordisk Investigational Site
Denver, Colorado, United States, 80262
4
Novo Nordisk Investigational Site
Indianapolis, Indiana, United States, 46290