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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-000100-40 | EudraCT Number |
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Trial terminated after recruiting 172 patients but without proceeding to the highest dosing cohort as this no longer reflects common clinical practice
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| activated recombinant human factor VII | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of critical, serious adverse events | Within 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical drainage volume | For the duration of the trial | |
| Amount of transfusions | For the duration of the trial |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Birmingham | Alabama | 35235 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19546387 | Result | 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. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| Tucson |
| Arizona |
| 85714 |
| United States |
| Novo Nordisk Investigational Site | San Francisco | California | 94115 | United States |
| Novo Nordisk Investigational Site | Denver | Colorado | 80262 | United States |
| Novo Nordisk Investigational Site | Atlanta | Georgia | 30322 | United States |
| Novo Nordisk Investigational Site | Baltimore | Maryland | 21287 | United States |
| Novo Nordisk Investigational Site | Boston | Massachusetts | 02215 | United States |
| Novo Nordisk Investigational Site | Camden | New Jersey | 08103 | United States |
| Novo Nordisk Investigational Site | Syracuse | New York | 13210 | United States |
| Novo Nordisk Investigational Site | The Bronx | New York | 10461 | United States |
| Novo Nordisk Investigational Site | The Bronx | New York | 10467 | United States |
| Novo Nordisk Investigational Site | Cleveland | Ohio | 44195 | United States |
| Novo Nordisk Investigational Site | Oklahoma City | Oklahoma | 73117 | United States |
| Novo Nordisk Investigational Site | Portland | Oregon | 97207 | United States |
| Novo Nordisk Investigational Site | Danville | Pennsylvania | 17821 | United States |
| Novo Nordisk Investigational Site | Houston | Texas | 77030 | United States |
| Novo Nordisk Investigational Site | Norfolk | Virginia | 23507 | United States |
| Novo Nordisk Investigational Site | Richmond | Virginia | 23298 | United States |
| Novo Nordisk Investigational Site | Buenos Aires | C1181ACH | Argentina |
| Novo Nordisk Investigational Site | Caba | C1093AAS | Argentina |
| Novo Nordisk Investigational Site | Capital Federal | 1209 | Argentina |
| Novo Nordisk Investigational Site | Corrientes | 3400 | Argentina |
| Novo Nordisk Investigational Site | Rosario | 2000 | Argentina |
| Novo Nordisk Investigational Site | São Paulo | 05403-000 | Brazil |
| Novo Nordisk Investigational Site | København Ø | 2100 | Denmark |
| Novo Nordisk Investigational Site | Nantes | 44093 | France |
| Novo Nordisk Investigational Site | Vandœuvre-lès-Nancy | 54511 | France |
| Novo Nordisk Investigational Site | Aachen | 52074 | Germany |
| Novo Nordisk Investigational Site | Berlin | 10117 | Germany |
| Novo Nordisk Investigational Site | Cologne | 50924 | Germany |
| Novo Nordisk Investigational Site | Frankfurt/M. | 60590 | Germany |
| Novo Nordisk Investigational Site | Krefeld | 47805 | Germany |
| Novo Nordisk Investigational Site | Leipzig | 04289 | Germany |
| Novo Nordisk Investigational Site | München | 80636 | Germany |
| Novo Nordisk Investigational Site | Ulm | 89075 | Germany |
| Novo Nordisk Investigational Site | Bangalore | 560 099 | India |
| Novo Nordisk Investigational Site | Chennai | 600 037 | India |
| Novo Nordisk Investigational Site | Chennai | 600101 | India |
| Novo Nordisk Investigational Site | New Delhi | 110025 | India |
| Novo Nordisk Investigational Site | Trivendrum | 695 011 | India |
| Novo Nordisk Investigational Site | Bologna | 40138 | Italy |
| Novo Nordisk Investigational Site | Milan | 20132 | Italy |
| Novo Nordisk Investigational Site | Roma | 00149 | Italy |
| Novo Nordisk Investigational Site | Roma | 00161 | Italy |
| Novo Nordisk Investigational Site | San Donato Milanese (MI) | 20097 | Italy |
| Novo Nordisk Investigational Site | Kuala Lumpur | 50400 | Malaysia |
| Novo Nordisk Investigational Site | Singapore | 168752 | Singapore |
| Novo Nordisk Investigational Site | Johannesburg | Gauteng | 2195 | South Africa |
| Novo Nordisk Investigational Site | Durban | KwaZulu-Natal | 4001 | South Africa |
| Novo Nordisk Investigational Site | Cape Town | Western Cape | 7550 | South Africa |
| Novo Nordisk Investigational Site | Barcelona | 08035 | Spain |
| Novo Nordisk Investigational Site | Bilbao | 48013 | Spain |
| Novo Nordisk Investigational Site | Madrid | 28006 | Spain |
| Novo Nordisk Investigational Site | Madrid | 28034 | Spain |
| Novo Nordisk Investigational Site | Madrid | 28046 | Spain |
| Novo Nordisk Investigational Site | Seville | 41013 | Spain |
| Novo Nordisk Investigational Site | Lund | 221 85 | Sweden |
| Novo Nordisk Investigational Site | Cambridge | CB3 8RE | United Kingdom |
| Novo Nordisk Investigational Site | Leicester | LE3 9QP | United Kingdom |
| Novo Nordisk Investigational Site | London | EC1A 7BE | United Kingdom |
| Novo Nordisk Investigational Site | London | SW3 6NP | United Kingdom |
| Novo Nordisk Investigational Site | London | W1G 8PH | United Kingdom |
| Novo Nordisk Investigational Site | Southampton | SO16 6YD | United Kingdom |