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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01562574
First received: March 22, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted

March 22, 2012
March 22, 2012
January 2002
August 2004   (final data collection date for primary outcome measure)
Time from reversal of heparin with protamine sulphate to chest closure [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 [ Designated as safety issue: No ]
  • Blood loss [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Activated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease
A Randomised, Double-blind, Parallel Group, Placebo-controlled Comparison of Recombi-nant Factor VIIa (rFVIIa/ NovoSeven®) With Standard Haemostatic Replacement Therapy, and Standard Haemostatic Replacement Ther-apy Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Acquired Bleeding Disorder
  • Cardiac Surgery Requiring Cardiopulmonary Bypass
  • 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
  • Experimental: Activated recombinant human factor VII
    Intervention: Drug: activated recombinant human factor VII
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
August 2004
August 2004   (final data collection date for primary outcome measure)

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
Both
up to 1 Year
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01562574
F7CPB-3343
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Jens Bjerre Novo Nordisk A/S
Novo Nordisk A/S
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP