NCT01563458
Completed
Phase 2
A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Dose Exploratory Trial Evaluating the Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in the Reduction of Bleeding in Subjects Undergoing Orthotopic Liver Transplantation
Overview
- Phase
- Phase 2
- Intervention
- activated recombinant human factor VII
- Conditions
- Acquired Bleeding Disorder
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 208
- Locations
- 1
- Primary Endpoint
- Total number of RBC units transfused during the perioperative period
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Scheduled to undergo orthotopic liver transplantation
- •Liver disease classified as Child-Turcotte (Pughs modification) score B or C
Exclusion Criteria
- •Previous liver transplantation
- •Scheduled multi-organ transplantation
- •Scheduled for living related donor transplantation
- •Present renal insufficiency requiring dialysis
- •Pregnancy
Arms & Interventions
High dose
Intervention: activated recombinant human factor VII
Low dose
Intervention: activated recombinant human factor VII
Placebo
Intervention: placebo
Outcomes
Primary Outcomes
Total number of RBC units transfused during the perioperative period
Secondary Outcomes
- Number of RBC units transfused by surgical phase
- Adverse events
- Changes in coagulation related parameters
Study Sites (1)
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