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
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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 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 |

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 |
- Time from reversal of heparin with protamine sulphate to chest closure
- 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

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Ages Eligible for Study: | up to 1 Year (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Australia | |
Novo Nordisk Investigational Site | |
Parkville, Australia, 3052 |
Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Publications of Results:
Responsible Party: | Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT01562574 |
Other Study ID Numbers: |
F7CPB-3343 |
First Posted: | March 26, 2012 Key Record Dates |
Last Update Posted: | January 12, 2017 |
Last Verified: | January 2017 |
Heart Diseases Hemostatic Disorders Blood Coagulation Disorders Cardiovascular Diseases |
Hematologic Diseases Vascular Diseases Hemorrhagic Disorders |