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

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

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
• Actual Primary Completion Date: August 2004
• Actual Study Completion Date: August 2004

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

• 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

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:

Clinical Trials at Novo Nordisk 

Publications of Results:

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.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT01562574
• Other Study ID Numbers: F7CPB-3343
• First Posted: March 26, 2012
• Last Update Posted: January 12, 2017
• Last Verified: January 2017

Additional relevant MeSH terms:

Heart Diseases; Hemostatic Disorders; Blood Coagulation Disorders; Cardiovascular Diseases; Hematologic Diseases; Vascular Diseases; Hemorrhagic Disorders