CompletedPhase 3

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

Australia82 participantsStarted 2002-01

Plain-language 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.

Who can participate

Age range1 Year

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Time from reversal of heparin with protamine sulphate to chest closure

Trial details

NCT IDNCT01562574

SponsorNovo Nordisk A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2004-08

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