Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
Conditions
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.
Interventions
DRUGactivated 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
DRUGplacebo
Up to three doses administered after surgery. If bleeding persisted after the third dose of trial product, conventional transfusion would be administered
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from reversal of heparin with protamine sulphate to chest closure | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Australia
Outcome results
None listed