Use of Activated Recombinant Human Factor VII in Cardiac Surgery
NCT ID: NCT00154427
Last Updated: 2017-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
172 participants
INTERVENTIONAL
2004-08-31
2007-11-30
Brief Summary
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The trial is planned to investigate the safety and efficacy of NovoSeven® in the management of post-operative bleeding in patients following cardiac surgery.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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activated recombinant human factor VII
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Birmingham, Alabama, United States
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
Atlanta, Georgia, United States
Novo Nordisk Investigational Site
Baltimore, Maryland, United States
Novo Nordisk Investigational Site
Boston, Massachusetts, United States
Novo Nordisk Investigational Site
Camden, New Jersey, United States
Novo Nordisk Investigational Site
Syracuse, 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
Oklahoma City, Oklahoma, United States
Novo Nordisk Investigational Site
Portland, Oregon, United States
Novo Nordisk Investigational Site
Danville, Pennsylvania, United States
Novo Nordisk Investigational Site
Houston, Texas, United States
Novo Nordisk Investigational Site
Norfolk, Virginia, United States
Novo Nordisk Investigational Site
Richmond, Virginia, United States
Novo Nordisk Investigational Site
Buenos Aires, , Argentina
Novo Nordisk Investigational Site
Caba, , Argentina
Novo Nordisk Investigational Site
Capital Federal, , Argentina
Novo Nordisk Investigational Site
Corrientes, , Argentina
Novo Nordisk Investigational Site
Rosario, , Argentina
Novo Nordisk Investigational Site
São Paulo, , Brazil
Novo Nordisk Investigational Site
København Ø, , Denmark
Novo Nordisk Investigational Site
Nantes, , France
Novo Nordisk Investigational Site
Vandœuvre-lès-Nancy, , France
Novo Nordisk Investigational Site
Aachen, , Germany
Novo Nordisk Investigational Site
Berlin, , Germany
Novo Nordisk Investigational Site
Cologne, , Germany
Novo Nordisk Investigational Site
Frankfurt/M., , Germany
Novo Nordisk Investigational Site
Krefeld, , Germany
Novo Nordisk Investigational Site
Leipzig, , Germany
Novo Nordisk Investigational Site
München, , Germany
Novo Nordisk Investigational Site
Ulm, , Germany
Novo Nordisk Investigational Site
Bangalore, , India
Novo Nordisk Investigational Site
Chennai, , India
Novo Nordisk Investigational Site
Chennai, , India
Novo Nordisk Investigational Site
New Delhi, , India
Novo Nordisk Investigational Site
Trivendrum, , India
Novo Nordisk Investigational Site
Bologna, , Italy
Novo Nordisk Investigational Site
Milan, , Italy
Novo Nordisk Investigational Site
Roma, , Italy
Novo Nordisk Investigational Site
Roma, , Italy
Novo Nordisk Investigational Site
San Donato Milanese (MI), , Italy
Novo Nordisk Investigational Site
Kuala Lumpur, , Malaysia
Novo Nordisk Investigational Site
Singapore, , Singapore
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, South Africa
Novo Nordisk Investigational Site
Cape Town, Western Cape, South Africa
Novo Nordisk Investigational Site
Barcelona, , Spain
Novo Nordisk Investigational Site
Bilbao, , Spain
Novo Nordisk Investigational Site
Madrid, , Spain
Novo Nordisk Investigational Site
Madrid, , Spain
Novo Nordisk Investigational Site
Madrid, , Spain
Novo Nordisk Investigational Site
Seville, , Spain
Novo Nordisk Investigational Site
Lund, , Sweden
Novo Nordisk Investigational Site
Cambridge, , United Kingdom
Novo Nordisk Investigational Site
Leicester, , United Kingdom
Novo Nordisk Investigational Site
London, , United Kingdom
Novo Nordisk Investigational Site
London, , United Kingdom
Novo Nordisk Investigational Site
London, , United Kingdom
Novo Nordisk Investigational Site
Southampton, , United Kingdom
Countries
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References
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Gill R, Herbertson M, Vuylsteke A, Olsen PS, von Heymann C, Mythen M, Sellke F, Booth F, Schmidt TA. Safety and efficacy of recombinant activated factor VII: a randomized placebo-controlled trial in the setting of bleeding after cardiac surgery. Circulation. 2009 Jul 7;120(1):21-7. doi: 10.1161/CIRCULATIONAHA.108.834275. Epub 2009 Jun 22.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2004-000100-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
F7CARD-1610
Identifier Type: -
Identifier Source: org_study_id
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