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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):

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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : January 2002
Primary Completion Date : August 2004
Study Completion Date : August 2004

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Time from reversal of heparin with protamine sulphate to chest closure

Secondary Outcome Measures :
  1. 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
  2. Blood loss
  3. Adverse events

Eligibility Criteria

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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01562574


Locations
Australia
Novo Nordisk Investigational Site
Parkville, Australia, 3052
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01562574     History of Changes
Other Study ID Numbers: F7CPB-3343
First Posted: March 26, 2012    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017

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