Use of Activated Recombinant Human Factor VII in Cardiac Surgery

NCT ID: NCT00154427

Last Updated: 2017-01-12

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2007-11-30

Brief Summary

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This trial is conducted in Africa, Asia, Europe, South America and the United States of America (USA).

The trial is planned to investigate the safety and efficacy of NovoSeven® in the management of post-operative bleeding in patients following cardiac surgery.

Detailed Description

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Conditions

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Acquired Bleeding Disorder Cardiac Surgery Requiring Cardiopulmonary Bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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activated recombinant human factor VII

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Post-operative bleeding according to pre-defined criteria for critical bleeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Novo Nordisk Investigational Site

Tucson, Arizona, United States

Site Status

Novo Nordisk Investigational Site

San Francisco, California, United States

Site Status

Novo Nordisk Investigational Site

Denver, Colorado, United States

Site Status

Novo Nordisk Investigational Site

Atlanta, Georgia, United States

Site Status

Novo Nordisk Investigational Site

Baltimore, Maryland, United States

Site Status

Novo Nordisk Investigational Site

Boston, Massachusetts, United States

Site Status

Novo Nordisk Investigational Site

Camden, New Jersey, United States

Site Status

Novo Nordisk Investigational Site

Syracuse, New York, United States

Site Status

Novo Nordisk Investigational Site

The Bronx, New York, United States

Site Status

Novo Nordisk Investigational Site

The Bronx, New York, United States

Site Status

Novo Nordisk Investigational Site

Cleveland, Ohio, United States

Site Status

Novo Nordisk Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

Novo Nordisk Investigational Site

Portland, Oregon, United States

Site Status

Novo Nordisk Investigational Site

Danville, Pennsylvania, United States

Site Status

Novo Nordisk Investigational Site

Houston, Texas, United States

Site Status

Novo Nordisk Investigational Site

Norfolk, Virginia, United States

Site Status

Novo Nordisk Investigational Site

Richmond, Virginia, United States

Site Status

Novo Nordisk Investigational Site

Buenos Aires, , Argentina

Site Status

Novo Nordisk Investigational Site

Caba, , Argentina

Site Status

Novo Nordisk Investigational Site

Capital Federal, , Argentina

Site Status

Novo Nordisk Investigational Site

Corrientes, , Argentina

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Novo Nordisk Investigational Site

Rosario, , Argentina

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Novo Nordisk Investigational Site

São Paulo, , Brazil

Site Status

Novo Nordisk Investigational Site

København Ø, , Denmark

Site Status

Novo Nordisk Investigational Site

Nantes, , France

Site Status

Novo Nordisk Investigational Site

Vandœuvre-lès-Nancy, , France

Site Status

Novo Nordisk Investigational Site

Aachen, , Germany

Site Status

Novo Nordisk Investigational Site

Berlin, , Germany

Site Status

Novo Nordisk Investigational Site

Cologne, , Germany

Site Status

Novo Nordisk Investigational Site

Frankfurt/M., , Germany

Site Status

Novo Nordisk Investigational Site

Krefeld, , Germany

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Novo Nordisk Investigational Site

Leipzig, , Germany

Site Status

Novo Nordisk Investigational Site

München, , Germany

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Novo Nordisk Investigational Site

Ulm, , Germany

Site Status

Novo Nordisk Investigational Site

Bangalore, , India

Site Status

Novo Nordisk Investigational Site

Chennai, , India

Site Status

Novo Nordisk Investigational Site

Chennai, , India

Site Status

Novo Nordisk Investigational Site

New Delhi, , India

Site Status

Novo Nordisk Investigational Site

Trivendrum, , India

Site Status

Novo Nordisk Investigational Site

Bologna, , Italy

Site Status

Novo Nordisk Investigational Site

Milan, , Italy

Site Status

Novo Nordisk Investigational Site

Roma, , Italy

Site Status

Novo Nordisk Investigational Site

Roma, , Italy

Site Status

Novo Nordisk Investigational Site

San Donato Milanese (MI), , Italy

Site Status

Novo Nordisk Investigational Site

Kuala Lumpur, , Malaysia

Site Status

Novo Nordisk Investigational Site

Singapore, , Singapore

Site Status

Novo Nordisk Investigational Site

Johannesburg, Gauteng, South Africa

Site Status

Novo Nordisk Investigational Site

Durban, KwaZulu-Natal, South Africa

Site Status

Novo Nordisk Investigational Site

Cape Town, Western Cape, South Africa

Site Status

Novo Nordisk Investigational Site

Barcelona, , Spain

Site Status

Novo Nordisk Investigational Site

Bilbao, , Spain

Site Status

Novo Nordisk Investigational Site

Madrid, , Spain

Site Status

Novo Nordisk Investigational Site

Madrid, , Spain

Site Status

Novo Nordisk Investigational Site

Madrid, , Spain

Site Status

Novo Nordisk Investigational Site

Seville, , Spain

Site Status

Novo Nordisk Investigational Site

Lund, , Sweden

Site Status

Novo Nordisk Investigational Site

Cambridge, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Leicester, , United Kingdom

Site Status

Novo Nordisk Investigational Site

London, , United Kingdom

Site Status

Novo Nordisk Investigational Site

London, , United Kingdom

Site Status

Novo Nordisk Investigational Site

London, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Southampton, , United Kingdom

Site Status

Countries

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United States Argentina Brazil Denmark France Germany India Italy Malaysia Singapore South Africa Spain Sweden United Kingdom

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.

Reference Type RESULT
PMID: 19546387 (View on PubMed)

Related Links

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http://novonordisk-trials.com

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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