A Phase 3 interventional study of activated recombinant human factor VII and placebo in Acquired Bleeding Disorder and Cardiac Surgery Requiring Cardiopulmonary Bypass, sponsored by Novo Nordisk A/S. Completed at 1 site in Australia. Open to participants aged Up to 1 Year. Per ClinicalTrials.gov, last updated 2017-01-12.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 82 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: activated recombinant human factor VII
Drug: placebo
Up to three doses administered after surgery. If bleeding persisted after the third dose of trial product, conventional transfusion would be administered
Up to three doses administered after surgery. If bleeding persisted after the third dose of trial product, conventional transfusion would be administered
Time from reversal of heparin with protamine sulphate to chest closure
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
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S