- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00154427
Use of Activated Recombinant Human Factor VII in Cardiac Surgery
January 11, 2017 updated by: Novo Nordisk A/S
A Multi-centre, Randomised, Double-blind, Placebocontrolled, Dose Escalation Trial on Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in the Treatment of Post-operative Bleeding in Patients Following Cardiac Surgery Requiring Cardiopulmonary Bypass
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.
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
172
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Buenos Aires, Argentina, C1181ACH
- Novo Nordisk INvestigational Site
-
Caba, Argentina, C1093AAS
- Novo Nordisk INvestigational Site
-
Capital Federal, Argentina, 1209
- Novo Nordisk INvestigational Site
-
Corrientes, Argentina, 3400
- Novo Nordisk INvestigational Site
-
Rosario, Argentina, 2000
- Novo Nordisk INvestigational Site
-
-
-
-
-
São Paulo, Brazil, 05403-000
- Novo Nordisk INvestigational Site
-
-
-
-
-
København ø, Denmark, 2100
- Novo Nordisk INvestigational Site
-
-
-
-
-
NANTES Cedex 1, France, 44093
- Novo Nordisk INvestigational Site
-
Vandoeuvre Les Nancy, France, 54511
- Novo Nordisk INvestigational Site
-
-
-
-
-
Aachen, Germany, 52074
- Novo Nordisk INvestigational Site
-
Berlin, Germany, 10117
- Novo Nordisk INvestigational Site
-
Frankfurt/M., Germany, 60590
- Novo Nordisk INvestigational Site
-
Krefeld, Germany, 47805
- Novo Nordisk INvestigational Site
-
Köln, Germany, 50924
- Novo Nordisk INvestigational Site
-
Leipzig, Germany, 04289
- Novo Nordisk INvestigational Site
-
München, Germany, 80636
- Novo Nordisk INvestigational Site
-
Ulm, Germany, 89075
- Novo Nordisk INvestigational Site
-
-
-
-
-
Bangalore, India, 560 099
- Novo Nordisk INvestigational Site
-
Chennai, India, 600 037
- Novo Nordisk INvestigational Site
-
Chennai, India, 600101
- Novo Nordisk INvestigational Site
-
New Delhi, India, 110025
- Novo Nordisk INvestigational Site
-
Trivendrum, India, 695 011
- Novo Nordisk INvestigational Site
-
-
-
-
-
Bologna, Italy, 40138
- Novo Nordisk INvestigational Site
-
Milano, Italy, 20132
- Novo Nordisk INvestigational Site
-
Roma, Italy, 00161
- Novo Nordisk INvestigational Site
-
Roma, Italy, 00149
- Novo Nordisk INvestigational Site
-
San Donato Milanese (MI), Italy, 20097
- Novo Nordisk INvestigational Site
-
-
-
-
-
Kuala Lumpur, Malaysia, 50400
- Novo Nordisk INvestigational Site
-
-
-
-
-
Singapore, Singapore, 168752
- Novo Nordisk INvestigational Site
-
-
-
-
Gauteng
-
Johannesburg, Gauteng, South Africa, 2195
- Novo Nordisk INvestigational Site
-
-
KwaZulu-Natal
-
Durban, KwaZulu-Natal, South Africa, 4001
- Novo Nordisk INvestigational Site
-
-
Western Cape
-
Cape Town, Western Cape, South Africa, 7550
- Novo Nordisk INvestigational Site
-
-
-
-
-
Barcelona, Spain, 08035
- Novo Nordisk INvestigational Site
-
Bilbao, Spain, 48013
- Novo Nordisk INvestigational Site
-
Madrid, Spain, 28006
- Novo Nordisk INvestigational Site
-
Madrid, Spain, 28046
- Novo Nordisk INvestigational Site
-
Madrid, Spain, 28034
- Novo Nordisk INvestigational Site
-
Sevilla, Spain, 41013
- Novo Nordisk INvestigational Site
-
-
-
-
-
Lund, Sweden, 221 85
- Novo Nordisk INvestigational Site
-
-
-
-
-
Cambridge, United Kingdom, CB3 8RE
- Novo Nordisk INvestigational Site
-
Leicester, United Kingdom, LE3 9QP
- Novo Nordisk INvestigational Site
-
London, United Kingdom, EC1A 7BE
- Novo Nordisk INvestigational Site
-
London, United Kingdom, SW3 6NP
- Novo Nordisk INvestigational Site
-
London, United Kingdom, W1G 8PH
- Novo Nordisk INvestigational Site
-
Southampton, United Kingdom, SO16 6YD
- Novo Nordisk INvestigational Site
-
-
-
-
Alabama
-
Birmingham, Alabama, United States, 35235
- Novo Nordisk INvestigational Site
-
-
Arizona
-
Tucson, Arizona, United States, 85714
- Novo Nordisk INvestigational Site
-
-
California
-
San Francisco, California, United States, 94115
- Novo Nordisk INvestigational Site
-
-
Colorado
-
Denver, Colorado, United States, 80262
- Novo Nordisk INvestigational Site
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Novo Nordisk INvestigational Site
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Novo Nordisk INvestigational Site
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Novo Nordisk INvestigational Site
-
-
New Jersey
-
Camden, New Jersey, United States, 08103
- Novo Nordisk INvestigational Site
-
-
New York
-
Bronx, New York, United States, 10467
- Novo Nordisk INvestigational Site
-
Bronx, New York, United States, 10461
- Novo Nordisk INvestigational Site
-
Syracuse, New York, United States, 13210
- Novo Nordisk INvestigational Site
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Novo Nordisk INvestigational Site
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73117
- Novo Nordisk INvestigational Site
-
-
Oregon
-
Portland, Oregon, United States, 97207
- Novo Nordisk INvestigational Site
-
-
Pennsylvania
-
Danville, Pennsylvania, United States, 17821
- Novo Nordisk INvestigational Site
-
-
Texas
-
Houston, Texas, United States, 77030
- Novo Nordisk INvestigational Site
-
-
Virginia
-
Norfolk, Virginia, United States, 23507
- Novo Nordisk INvestigational Site
-
Richmond, Virginia, United States, 23298
- Novo Nordisk INvestigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Post-operative bleeding according to pre-defined criteria for critical bleeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of critical, serious adverse events
Time Frame: Within 30 days
|
Within 30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Surgical drainage volume
Time Frame: For the duration of the trial
|
For the duration of the trial
|
Amount of transfusions
Time Frame: For the duration of the trial
|
For the duration of the trial
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2004
Primary Completion (Actual)
November 1, 2007
Study Completion (Actual)
November 1, 2007
Study Registration Dates
First Submitted
September 9, 2005
First Submitted That Met QC Criteria
September 9, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Estimate)
January 12, 2017
Last Update Submitted That Met QC Criteria
January 11, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- F7CARD-1610
- 2004-000100-40 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acquired Bleeding Disorder
-
Novo Nordisk A/SCompletedCongenital Bleeding Disorder | Acquired Bleeding Disorder | Acquired Haemophilia | Congenital FVII Deficiency | Glanzmann's DiseaseGermany
-
Novo Nordisk A/SCompletedAcquired Bleeding Disorder | Bleeding During/Following SurgeryIsrael, Sweden, United Kingdom, Germany, Switzerland, France, Spain, Italy, Thailand, Denmark, United States, Poland, Finland, Singapore, Australia, Austria
-
Novo Nordisk A/STerminatedAcquired Bleeding Disorder | Bleeding During/Following SurgeryUnited States
-
Novo Nordisk A/SCompletedAcquired Bleeding Disorder | Bleeding During/Following SurgeryGermany, Sweden, United Kingdom, Spain, Canada, Australia, France
-
Novo Nordisk A/SCompletedAcquired Bleeding Disorder | Acquired HaemophiliaFrance
-
Novo Nordisk A/SCompletedTrauma | Acquired Bleeding DisorderGermany, Austria, Israel, France, Canada, Singapore, South Africa, Australia, United Kingdom
-
Novo Nordisk A/STerminatedTrauma | Acquired Bleeding DisorderSpain, Hong Kong, Germany, France, United Kingdom, Brazil, Italy, Hungary, Netherlands, United States, Switzerland, Czech Republic, Greece, South Africa
-
Novo Nordisk A/SWithdrawnTrauma | Acquired Bleeding DisorderUnited States
-
Novo Nordisk A/SCompletedHealthy | Congenital Bleeding Disorder | Haemophilia A With Inhibitors | Haemophilia B With Inhibitors | Acquired Bleeding Disorder | Acquired Haemophilia | Congenital FVII Deficiency | Glanzmann's DiseaseFrance
-
Novo Nordisk A/SCompletedSpinal Fusion | Acquired Bleeding DisorderUnited States
Clinical Trials on activated recombinant human factor VII
-
Novo Nordisk A/SCompletedTrauma | Acquired Bleeding DisorderUnited States, Canada
-
Novo Nordisk A/SCompletedHealthy | Congenital Bleeding Disorder | Haemophilia A With Inhibitors | Haemophilia B With Inhibitors | Acquired Bleeding Disorder | Acquired Haemophilia | Congenital FVII Deficiency | Glanzmann's DiseaseFrance
-
Novo Nordisk A/SCompletedAcquired Bleeding Disorder | Intracerebral HaemorrhageSpain, Sweden, Singapore, Norway, Italy, Switzerland, Australia, Austria, Belgium, Canada, Denmark, Finland, Germany, Netherlands, United Kingdom
-
Novo Nordisk A/SCompletedHealthy | Congenital Bleeding DisorderUnited States
-
Novo Nordisk A/SCompletedCongenital Bleeding Disorder | Haemophilia A | Haemophilia BFrance, Israel, Germany
-
Novo Nordisk A/SCompletedOther Haemostasis Disorder | Haemorrhagic CystitisUnited States
-
Novo Nordisk A/SCompletedCongenital Bleeding Disorder | Haemophilia A With Inhibitors | Haemophilia B With InhibitorsFrance, United Kingdom, Spain, Israel, Poland, Turkey, Hungary
-
Novo Nordisk A/SCompletedObservational Study on Safety and Efficacy of NovoSeven® in Subjects With Congenital FVII DeficiencyCongenital Bleeding Disorder | Congenital FVII DeficiencyJapan
-
Novo Nordisk A/SCompletedCirrhosis | Acquired Bleeding DisorderGermany, United Kingdom, Spain, Taiwan, France, Italy, Austria, Czech Republic, Poland, Denmark, Finland, Hong Kong
-
Novo Nordisk A/SCompletedTrauma | Acquired Bleeding DisorderIndia, Spain, Canada, Finland, Germany, Israel, Italy, Netherlands, Singapore, Switzerland, Taiwan