Safety and Efficacy of Activated Recombinant Human Factor VII in Patients Undergoing Orthotopic Liver Transplantation

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acquired Bleeding Disorder, Bleeding During/Following Surgery

Intervention / Treatment
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* Drug: activated recombinant human factor VII
* Drug: activated recombinant human factor VII
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High dose<br> | Drug: activated recombinant human factor VII<br>* 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<br>|
| Experimental: Low dose<br> | Drug: activated recombinant human factor VII<br>* 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<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of RBC units transfused during the perioperative period |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of RBC units transfused by surgical phase |  |  | 
| Adverse events |  |  | 
| Changes in coagulation related parameters |  |  |