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

PHASE3CompletedINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

January 31, 2002

Primary Completion Date

August 31, 2004

Study Completion Date

August 31, 2004

Conditions
Acquired Bleeding DisorderCardiac Surgery Requiring Cardiopulmonary Bypass
Interventions
DRUG

activated 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

DRUG

placebo

Up to three doses administered after surgery. If bleeding persisted after the third dose of trial product, conventional transfusion would be administered

Trial Locations (1)

3052

Novo Nordisk Investigational Site, Parkville

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY