NCT01562574

Activated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease

A Randomised, Double-blind, Parallel Group, Placebo-controlled Comparison of Recombi-nant Factor VIIa (rFVIIa/ NovoSeven®) With Standard Haemostatic Replacement Therapy, and Standard Haemostatic Replacement Ther-apy Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

This trial is conducted in Oceania. The aim of this trial is to investigate the efficacy of activated recombinant human factor VII and standard treatment compared with standard haemostatic replacement therapy in cardiopulmonary bypass (CPB) surgery for paediatric congenital heart disease.

Conditions

• Acquired Bleeding Disorder
• Cardiac Surgery Requiring Cardiopulmonary Bypass

Interventions

Type	Name	Description
DRUG	activated recombinant human factor VII	Up to three doses administered after surgery. If bleeding persisted after the third dose of trial product, conventional transfusion would be administered
DRUG	placebo	Up to three doses administered after surgery. If bleeding persisted after the third dose of trial product, conventional transfusion would be administered

Timeline

• Start date: 2002-01-01
• Primary completion: 2004-08-01
• Completion: 2004-08-01
• First posted: 2012-03-26
• Last updated: 2017-01-12

Locations

1 site across 1 country: Australia