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

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Cardiac Surgery Requiring Cardiopulmonary Bypass; Acquired Bleeding Disorder

Treatments: Drug: activated recombinant human factor VII; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01562574

F7CPB-3343

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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82 participants in 2 patient groups, including a placebo group

Activated recombinant human factor VII

Experimental group

Treatment:

Drug: activated recombinant human factor VII

Placebo

Placebo Comparator group

Treatment:

Drug: placebo