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

Novo Nordisk A/S82 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Acquired Bleeding Disorder Cardiac Surgery Requiring Cardiopulmonary Bypass

Interventions

activated recombinant human factor VIIDRUG

Up to three doses administered after surgery. If bleeding persisted after the third dose of trial product, conventional transfusion would be administered

placeboDRUG

Up to three doses administered after surgery. If bleeding persisted after the third dose of trial product, conventional transfusion would be administered

Eligibility

Sex: ALLMax age: 1 Year

Medical Language ↔ Plain English

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) Exclusion Criteria: * Congenital heart disease that does not require CPB surgery

Locations (1)

Novo Nordisk Investigational Site

Parkville, Australia

Outcomes

Primary Outcomes

Time from reversal of heparin with protamine sulphate to chest closure

Secondary Outcomes

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

Data from ClinicalTrials.gov

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