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

Tracking Information

• First Submitted Date: March 22, 2012
• First Posted Date: March 26, 2012
• Last Update Posted Date: January 12, 2017
• Study Start Date: January 2002
• Actual Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 22, 2012): Time from reversal of heparin with protamine sulphate to chest closure
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Acquired Bleeding Disorder
• Cardiac Surgery Requiring Cardiopulmonary Bypass

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 22, 2012): 82
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: August 2004
• Actual Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 1 Year (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia

Administrative Information

• NCT Number: NCT01562574
• Other Study ID Numbers: F7CPB-3343
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Novo Nordisk A/S
• Study Sponsor: Novo Nordisk A/S
• Collaborators: Not Provided

Investigators

• Study Director: Global Clinical Registry (GCR, 1452); Novo Nordisk A/S

• PRS Account: Novo Nordisk A/S
• Verification Date: January 2017