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

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ClinicalTrials.gov Identifier: NCT01562574
Recruitment Status : Completed
First Posted : March 26, 2012
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE March 22, 2012
First Posted Date  ICMJE March 26, 2012
Last Update Posted Date January 12, 2017
Study Start Date  ICMJE January 2002
Actual Primary Completion Date August 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2012)
Time from reversal of heparin with protamine sulphate to chest closure
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2012)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Activated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Acquired Bleeding Disorder
  • Cardiac Surgery Requiring Cardiopulmonary Bypass
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Activated recombinant human factor VII
    Intervention: Drug: activated recombinant human factor VII
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 22, 2012)
82
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2004
Actual Primary Completion Date August 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 1 Year   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01562574
Other Study ID Numbers  ICMJE F7CPB-3343
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date January 2017

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