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This trial is conducted in Asia. The aim of this trial is to evaluate the haemostatic efficacy of activated recombinant human factor VII in cirrhotic patients scheduled to undergo partial hepatectomy due to liver cancer or benign tumours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose | Experimental |
| |
| High dose | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| activated recombinant human factor VII | Drug | An initial bolus dose of 50 mcg/kg body weight (BW) followed by 50 mcg/kg BW every second hour until completion of surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| The RBC transfusion requirements |
| Measure | Description | Time Frame |
|---|---|---|
| Number of transfusion product units | ||
| Change in coagulation-related parameters | ||
| Adverse events |
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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 | Beijing | Beijing Municipality | 100021 | China | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16442954 | Result | Shao YF, Yang JM, Chau GY, Sirivatanauksorn Y, Zhong SX, Erhardtsen E, Nivatvongs S, Lee PH. Safety and hemostatic effect of recombinant activated factor VII in cirrhotic patients undergoing partial hepatectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Am J Surg. 2006 Feb;191(2):245-9. doi: 10.1016/j.amjsurg.2005.10.019. | |
| 16734808 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| activated recombinant human factor VII | Drug | An initial bolus dose of 100 mcg/kg body weight (BW) followed by 100 mcg/kg BW every second hour until completion of surgery |
|
| placebo | Drug | An initial placebo bolus dose followed by placebo every second hour until completion of surgery |
|
| Shanghai |
| Shanghai Municipality |
| 200438 |
| China |
| Novo Nordisk Investigational Site | Beijing | China |
| Novo Nordisk Investigational Site | Taipei | 100 | Taiwan |
| Novo Nordisk Investigational Site | Taipei | 112 | Taiwan |
| Novo Nordisk Investigational Site | Bangkok | 10330 | Thailand |
| Novo Nordisk Investigational Site | Bangkok | 10700 | Thailand |
| 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. |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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