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

Phase 3

Completed

• Conditions: Acquired Bleeding Disorder; Cardiac Surgery Requiring Cardiopulmonary Bypass
• Interventions: Drug: placebo; Drug: activated recombinant human factor VII

• Registration Number: NCT01562574
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-01
• Primary Completion: 2004-08
• Study Completion: 2004-08
• Study First Submitted: 2012-03-22
• Study First Submitted QC: 2012-03-22
• Study First Posted: 2012-03-26
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• Signed informed consent obtained from parent or legal guardian before any trial-related activities. Trial-related activities are any procedure that would not have been performed during normal management of the subject
• Children with complex congenital heart disease requiring corrective surgery with cardiopulmonary bypass (CPB)

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Exclusion Criteria

• Congenital heart disease that does not require CPB surgery

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
Activated recombinant human factor VII	activated recombinant human factor VII	-

Primary Outcome Measures

Name	Time	Method
Time from reversal of heparin with protamine sulphate to chest closure

Secondary Outcome Measures

Name	Time	Method
Number of units/volume of fresh frozen plasma (FFP) and/or platelets and/or red-cell concentrates transfused during surgery and in the post-surgery period
Blood loss
Adverse events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇦🇺 Parkville, Australia