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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
ClinicalTrials.gov Identifier:
NCT01562574
First received: March 22, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Acquired Bleeding Disorder
Cardiac Surgery Requiring Cardiopulmonary Bypass
 Drug: activated recombinant human factor VII
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Time from reversal of heparin with protamine sulphate to chest closure [ Designated as safety issue: No ]

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 [ Designated as safety issue: No ]
  • Blood loss [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: January 2002
Study Completion Date: August 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Activated recombinant human factor VII 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
Placebo Comparator: Placebo Drug: placebo
Up to three doses administered after surgery. If bleeding persisted after the third dose of trial product, conventional transfusion would be administered

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562574

Locations
Australia
Parkville, Australia, 3052
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Jens Bjerre Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01562574     History of Changes
Other Study ID Numbers: F7CPB-3343
Study First Received: March 22, 2012
Last Updated: March 22, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
Heart Diseases
Hemorrhage
Heart Defects, Congenital
 Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on May 23, 2013