A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial Evaluating the Safety and Efficacy of A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial Evaluating the Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Cirrhotic Patients Scheduled to Undergo Partial Hepatectomy Due to Liver Cancer or Benign Tumours
21 Years
70 Years
Both
Acquired Bleeding Disorder, Cirrhosis
Trial Information
A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial Evaluating the Safety and Efficacy of A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial Evaluating the Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Cirrhotic Patients Scheduled to Undergo Partial Hepatectomy Due to Liver Cancer or Benign Tumours
Inclusion Criteria:
- Cirrhosis (Child-Turcotte Score A, B, or C)
- Scheduled to undergo partial hepatectomy due to liver cancer or benign tumours
Exclusion Criteria:
- Portal vein thrombosis
- Clinically documented DVT (deep venous thrombosis)
- Clinically documented symptoms of severe cardiovascular disease and/or previous
myocardial/pulmonary infarction or stroke
- Present renal insufficiency requiring dialysis
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
The RBC transfusion requirements
Safety Issue:
No
Principal Investigator
Peter B. Schelde
Investigator Role:
Study Director
Investigator Affiliation:
Novo Nordisk
Authority:
Taiwan: Department of Health
Study ID:
F7LIVER-1313
NCT ID:
NCT01562821
Start Date:
July 2001
Completion Date:
December 2002
Related Keywords:
- Acquired Bleeding Disorder
- Cirrhosis
- Blood Coagulation Disorders
- Hemostatic Disorders
- Hemorrhagic Disorders
- Hemorrhage
- Liver Cirrhosis
- Fibrosis
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