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Use of Activated Recombinant Human Factor VII in Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT00154427
Recruitment Status : Terminated (Trial terminated after recruiting 172 patients but without proceeding to the highest dosing cohort as this no longer reflects common clinical practice)
First Posted : September 12, 2005
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:

This trial is conducted in Africa, Asia, Europe, South America and the United States of America (USA).

The trial is planned to investigate the safety and efficacy of NovoSeven® in the management of post-operative bleeding in patients following cardiac surgery.


Condition or disease Intervention/treatment Phase
Acquired Bleeding Disorder Cardiac Surgery Requiring Cardiopulmonary Bypass Drug: activated recombinant human factor VII Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-centre, Randomised, Double-blind, Placebocontrolled, Dose Escalation Trial on Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in the Treatment of Post-operative Bleeding in Patients Following Cardiac Surgery Requiring Cardiopulmonary Bypass
Study Start Date : August 2004
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery




Primary Outcome Measures :
  1. Incidence of critical, serious adverse events [ Time Frame: Within 30 days ]

Secondary Outcome Measures :
  1. Surgical drainage volume [ Time Frame: For the duration of the trial ]
  2. Amount of transfusions [ Time Frame: For the duration of the trial ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Post-operative bleeding according to pre-defined criteria for critical bleeding

Information from the National Library of Medicine

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): NCT00154427


  Show 63 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00154427     History of Changes
Other Study ID Numbers: F7CARD-1610
2004-000100-40 ( EudraCT Number )
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Hemorrhage
Blood Coagulation Disorders
Hemostatic Disorders
Pathologic Processes
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders