Back to resultsActivated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease
Primary Purpose
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
activated recombinant human factor VII
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acquired Bleeding Disorder
Eligibility Criteria
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
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Activated recombinant human factor VII
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Time from reversal of heparin with protamine sulphate to chest closure
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01562574
Brief Title
Activated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
August 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Activated recombinant human factor VII
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
activated recombinant human factor VII
Intervention Description
Up to three doses administered after surgery. If bleeding persisted after the third dose of trial product, conventional transfusion would be administered
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Up to three doses administered after surgery. If bleeding persisted after the third dose of trial product, conventional transfusion would be administered
Primary Outcome Measure Information:
Title
Time from reversal of heparin with protamine sulphate to chest closure
Secondary Outcome Measure Information:
Title
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
Title
Blood loss
Title
Adverse events
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Parkville
ZIP/Postal Code
3052
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
16788315
Citation
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.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Activated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease
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