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

NCT01562574 | Completed Phase 3

• 1 other identifier: F7CPB-3343
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Acquired Bleeding Disorder; Cardiac Surgery Requiring Cardiopulmonary Bypass

Outcome Measures

Primary Outcomes (1)

• Time from reversal of heparin with protamine sulphate to chest closure

Secondary Outcomes (3)

• 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

Study Arms (2)

Activated recombinant human factor VII

EXPERIMENTAL

Drug: activated recombinant human factor VII

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

activated recombinant human factor VII DRUG

Up to three doses administered after surgery. If bleeding persisted after the third dose of trial product, conventional transfusion would be administered

Activated recombinant human factor VII

placebo DRUG

Up to three doses administered after surgery. If bleeding persisted after the third dose of trial product, conventional transfusion would be administered

Placebo

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• Congenital heart disease that does not require CPB surgery

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Parkville, 3052, Australia

Location

Related Publications (1)

• 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.

  PMID: 16788315 RESULT

Related Links

• Clinical Trials at Novo Nordisk

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2012
• First Posted: March 26, 2012
• Study Start: January 1, 2002
• Primary Completion: August 1, 2004
• Study Completion: August 1, 2004
• Last Updated: January 12, 2017

Record last verified: 2017-01

Locations

AU (1)