Safety of rFXIII in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass

Completed · Phase 1 · Has a placebo group

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

In brief

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) administered following first time myocardial revascularization requiring cardiopulmonary bypass (CPB).

Key facts

Study ID

NCT02239146

Run by

Novo Nordisk A/S

People needed

43

Starts

2005-10-01

Expected to finish

2008-01-01

Last updated by the study team

2017-01-11

Who can join

Age: 35 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is undergoing his/her first myocardial revascularization

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Tucson, Arizona, United States
• Novo Nordisk Investigational Site — San Francisco, California, United States
• Novo Nordisk Investigational Site — Denver, Colorado, United States
• Novo Nordisk Investigational Site — Indianapolis, Indiana, United States
• Novo Nordisk Investigational Site — Camden, New Jersey, United States
• Novo Nordisk Investigational Site — New York, New York, United States
• Novo Nordisk Investigational Site — The Bronx, New York, United States
• Novo Nordisk Investigational Site — The Bronx, New York, United States
• Novo Nordisk Investigational Site — Cleveland, Ohio, United States
• Novo Nordisk Investigational Site — Portland, Oregon, 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 — Houston, Texas, United States
• Novo Nordisk Investigational Site — Richmond, Virginia, United States
• Novo Nordisk Investigational Site — Toronto, Canada
• Novo Nordisk Investigational Site — København Ø, Denmark
• Novo Nordisk Investigational Site — Hamburg, Germany
• Novo Nordisk Investigational Site — Lahr, Germany
• Novo Nordisk Investigational Site — Mainz, Germany
• Novo Nordisk Investigational Site — Cambridge, United Kingdom
• Novo Nordisk Investigational Site — London, United Kingdom
• Novo Nordisk Investigational Site — Middlesbrough, United Kingdom
• Novo Nordisk Investigational Site — Southampton, United Kingdom

Full record on ClinicalTrials.gov

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