Use of Activated Recombinant Human Factor VII in Cardiac Surgery

January 11, 2017 updated by: Novo Nordisk A/S

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina, C1181ACH
        • Novo Nordisk INvestigational Site
      • Caba, Argentina, C1093AAS
        • Novo Nordisk INvestigational Site
      • Capital Federal, Argentina, 1209
        • Novo Nordisk INvestigational Site
      • Corrientes, Argentina, 3400
        • Novo Nordisk INvestigational Site
      • Rosario, Argentina, 2000
        • Novo Nordisk INvestigational Site
      • São Paulo, Brazil, 05403-000
        • Novo Nordisk INvestigational Site
      • København ø, Denmark, 2100
        • Novo Nordisk INvestigational Site
      • NANTES Cedex 1, France, 44093
        • Novo Nordisk INvestigational Site
      • Vandoeuvre Les Nancy, France, 54511
        • Novo Nordisk INvestigational Site
      • Aachen, Germany, 52074
        • Novo Nordisk INvestigational Site
      • Berlin, Germany, 10117
        • Novo Nordisk INvestigational Site
      • Frankfurt/M., Germany, 60590
        • Novo Nordisk INvestigational Site
      • Krefeld, Germany, 47805
        • Novo Nordisk INvestigational Site
      • Köln, Germany, 50924
        • Novo Nordisk INvestigational Site
      • Leipzig, Germany, 04289
        • Novo Nordisk INvestigational Site
      • München, Germany, 80636
        • Novo Nordisk INvestigational Site
      • Ulm, Germany, 89075
        • Novo Nordisk INvestigational Site
      • Bangalore, India, 560 099
        • Novo Nordisk INvestigational Site
      • Chennai, India, 600 037
        • Novo Nordisk INvestigational Site
      • Chennai, India, 600101
        • Novo Nordisk INvestigational Site
      • New Delhi, India, 110025
        • Novo Nordisk INvestigational Site
      • Trivendrum, India, 695 011
        • Novo Nordisk INvestigational Site
      • Bologna, Italy, 40138
        • Novo Nordisk INvestigational Site
      • Milano, Italy, 20132
        • Novo Nordisk INvestigational Site
      • Roma, Italy, 00161
        • Novo Nordisk INvestigational Site
      • Roma, Italy, 00149
        • Novo Nordisk INvestigational Site
      • San Donato Milanese (MI), Italy, 20097
        • Novo Nordisk INvestigational Site
      • Kuala Lumpur, Malaysia, 50400
        • Novo Nordisk INvestigational Site
      • Singapore, Singapore, 168752
        • Novo Nordisk INvestigational Site
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2195
        • Novo Nordisk INvestigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4001
        • Novo Nordisk INvestigational Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7550
        • Novo Nordisk INvestigational Site
      • Barcelona, Spain, 08035
        • Novo Nordisk INvestigational Site
      • Bilbao, Spain, 48013
        • Novo Nordisk INvestigational Site
      • Madrid, Spain, 28006
        • Novo Nordisk INvestigational Site
      • Madrid, Spain, 28046
        • Novo Nordisk INvestigational Site
      • Madrid, Spain, 28034
        • Novo Nordisk INvestigational Site
      • Sevilla, Spain, 41013
        • Novo Nordisk INvestigational Site
      • Lund, Sweden, 221 85
        • Novo Nordisk INvestigational Site
      • Cambridge, United Kingdom, CB3 8RE
        • Novo Nordisk INvestigational Site
      • Leicester, United Kingdom, LE3 9QP
        • Novo Nordisk INvestigational Site
      • London, United Kingdom, EC1A 7BE
        • Novo Nordisk INvestigational Site
      • London, United Kingdom, SW3 6NP
        • Novo Nordisk INvestigational Site
      • London, United Kingdom, W1G 8PH
        • Novo Nordisk INvestigational Site
      • Southampton, United Kingdom, SO16 6YD
        • Novo Nordisk INvestigational Site
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Novo Nordisk INvestigational Site
    • Arizona
      • Tucson, Arizona, United States, 85714
        • Novo Nordisk INvestigational Site
    • California
      • San Francisco, California, United States, 94115
        • Novo Nordisk INvestigational Site
    • Colorado
      • Denver, Colorado, United States, 80262
        • Novo Nordisk INvestigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Novo Nordisk INvestigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Novo Nordisk INvestigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Novo Nordisk INvestigational Site
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Novo Nordisk INvestigational Site
    • New York
      • Bronx, New York, United States, 10467
        • Novo Nordisk INvestigational Site
      • Bronx, New York, United States, 10461
        • Novo Nordisk INvestigational Site
      • Syracuse, New York, United States, 13210
        • Novo Nordisk INvestigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Novo Nordisk INvestigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73117
        • Novo Nordisk INvestigational Site
    • Oregon
      • Portland, Oregon, United States, 97207
        • Novo Nordisk INvestigational Site
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17821
        • Novo Nordisk INvestigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • Novo Nordisk INvestigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Novo Nordisk INvestigational Site
      • Richmond, Virginia, United States, 23298
        • Novo Nordisk INvestigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of critical, serious adverse events
Time Frame: Within 30 days
Within 30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Surgical drainage volume
Time Frame: For the duration of the trial
For the duration of the trial
Amount of transfusions
Time Frame: For the duration of the trial
For the duration of the trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • F7CARD-1610
  • 2004-000100-40 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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