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This trial is conducted in Europe, North America and Oceania. The aim of this trial is to evaluate the haemostatic efficacy of activated recombinant human factor VII in subjects undergoing orthotopic liver transplantation surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose | Experimental |
| |
| Low dose | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| activated recombinant human factor VII | Drug | 120 mcg/kg into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. 120 mcg/kg single bolus administration at completion of wound closure |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of RBC units transfused during the perioperative period |
| Measure | Description | Time Frame |
|---|---|---|
| Number of RBC units transfused by surgical phase | ||
| Adverse events | ||
| Changes in coagulation related parameters |
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Inclusion Criteria:
Exclusion 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 | Camperdown | 2050 | Australia | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16035095 | Result | Lodge JP, Jonas S, Jones RM, Olausson M, Mir-Pallardo J, Soefelt S, Garcia-Valdecasas JC, McAlister V, Mirza DF; rFVIIa OLT Study Group. Efficacy and safety of repeated perioperative doses of recombinant factor VIIa in liver transplantation. Liver Transpl. 2005 Aug;11(8):973-9. doi: 10.1002/lt.20470. | |
| 16734808 | Result |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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|
| activated recombinant human factor VII | Drug | 60 mcg/kg into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. 60 mcg/kg single bolus administration at completion of wound closure |
|
| placebo | Drug | Trial drug into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. Single bolus administration at completion of wound closure |
|
| Heidelberg |
| 3084 |
| Australia |
| Novo Nordisk Investigational Site | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Novo Nordisk Investigational Site | London | N6A 5A5 | Canada |
| Novo Nordisk Investigational Site | Québec | H3H1A1 | Canada |
| Novo Nordisk Investigational Site | Toronto | M5G-2C4 | Canada |
| Novo Nordisk Investigational Site | Clichy | 92 188 | France |
| Novo Nordisk Investigational Site | Berlin | 13353 | Germany |
| Novo Nordisk Investigational Site | Essen | 45122 | Germany |
| Novo Nordisk Investigational Site | Barakaldo | 48903 | Spain |
| Novo Nordisk Investigational Site | Barcelona | 08036 | Spain |
| Novo Nordisk Investigational Site | Valencia | 46026 | Spain |
| Novo Nordisk Investigational Site | Gothenburg | 413 45 | Sweden |
| Novo Nordisk Investigational Site | Stockholm | 141 86 | Sweden |
| Novo Nordisk Investigational Site | Birmingham | B15 2TH | United Kingdom |
| Novo Nordisk Investigational Site | Edinburgh | United Kingdom |
| Novo Nordisk Investigational Site | Leeds | LS9 7TS | United Kingdom |
| Novo Nordisk Investigational Site | London | SE5 9RS | United Kingdom |
| Levy JH, Fingerhut A, Brott T, Langbakke IH, Erhardtsen E, Porte RJ. Recombinant factor VIIa in patients with coagulopathy secondary to anticoagulant therapy, cirrhosis, or severe traumatic injury: review of safety profile. Transfusion. 2006 Jun;46(6):919-33. doi: 10.1111/j.1537-2995.2006.00824.x. |