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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-000088-92 | EudraCT Number |
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This trial is conducted in Asia, Europe, Middle East, and North America. The primary objective of the trial is to evaluate the safety of Recombinant Activated Factor VII in patients with brain contusions. The secondary objective of the trial is to evaluate the preliminary efficacy of Recombinant Activated Factor VII in preventing early haemorrhagic progression in contusive brain injury.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| activated recombinant human factor VII | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Safety of Recombinant Activated Factor VII in Subjects with Brain Contusions | Within the first 15 days of injury |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the preliminary efficacy of Recombinant Activated Factor VII in preventing haemorrhagic progression in brain contusions |
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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 | Montreal | H3G 1A4 | Canada | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18496183 | Result | Narayan RK, Maas AI, Marshall LF, Servadei F, Skolnick BE, Tillinger MN; rFVIIa Traumatic ICH Study Group. Recombinant factor VIIA in traumatic intracerebral hemorrhage: results of a dose-escalation clinical trial. Neurosurgery. 2008 Apr;62(4):776-86; discussion 786-8. doi: 10.1227/01.neu.0000316898.78371.74. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| Helsinki |
| 00250 |
| Finland |
| Novo Nordisk Investigational Site | Hanover | 30625 | Germany |
| Novo Nordisk Investigational Site | New Dehli | New Delhi | 110029 | India |
| Novo Nordisk Investigational Site | Bangalore | 560017 | India |
| Novo Nordisk Investigational Site | Haifa | 31096 | Israel |
| Novo Nordisk Investigational Site | Ramat Gan | 52621 | Israel |
| Novo Nordisk Investigational Site | Tel Aviv | 64239 | Israel |
| Novo Nordisk Investigational Site | Cesena | 47023 | Italy |
| Novo Nordisk Investigational Site | Rotterdam | 3015 GD | Netherlands |
| Novo Nordisk Investigational Site | Singapore | 119074 | Singapore |
| Novo Nordisk Investigational Site | Singapore | 308443 | Singapore |
| Novo Nordisk Investigational Site | Barcelona | 08035 | Spain |
| Novo Nordisk Investigational Site | Zurich | 8091 | Switzerland |
| Novo Nordisk Investigational Site | Taoyuan | 333 | Taiwan |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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