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

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.

Timeline

Start

2002-01

Primary completion

2004-08

Completion

2004-08

Publications

• Results Ekert H, Brizard C, Eyers R, Cochrane A, Henning R. Elective administration in infants of low-dose recombinant activated factor VII (rFVIIa) in cardiopulmonary bypass surgery for congenital heart disease does not shorten time to chest closure or reduce blood loss and need for transfusions: a randomized, double-blind, parallel group, placebo-controlled study of rFVIIa and standard haemostatic replacement therapy versus standard haemostatic replacement therapy. Blood Coagul Fibrinolysis. 2006 Jul;17(5):389-95. doi: 10.1097/01.mbc.0000233369.03358.c1.

Drugs

Indications