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Use of Activated Recombinant FVII in Spinal Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00102037
First Posted: January 20, 2005
Last Update Posted: January 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This trial is conducted in the United States of America (USA). The purpose of this clinical research trial is to understand how safe and effective Recombinant Activated FVII is for reducing bleeding and blood transfusions in patients undergoing spinal fusion surgery.

Condition Intervention Phase
Acquired Bleeding Disorder Spinal Fusion Drug: eptacog alfa (activated) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Safety of Activated Recombinant FVII as an Add-On Therapy in Spinal Surgery

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Safety variables [ Time Frame: Within 30 days after surgery ]

Secondary Outcome Measures:
  • Efficacy variables

Enrollment: 50
Study Start Date: July 2004
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: eptacog alfa (activated)
    Other Name: activated recombinant human factor VII
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective spinal fusion surgery.

Exclusion Criteria:

  • History of thrombotic disorders (myocardial infarction, deep vein thrombosis, pulmonary embolism, stroke, disseminated intravascular coagulation or peripheral artery thrombosis)
  • Any trauma within the last 3 months leading to hospitalization > 24 hours
  • Angina or known coronary artery disease
  Contacts and Locations
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): NCT00102037


Locations
United States, California
Novo Nordisk Investigational Site
Sacramento, California, United States, 95817
Novo Nordisk Investigational Site
San Francisco, California, United States, 94143-0728
United States, District of Columbia
Novo Nordisk Investigational Site
Washington, District of Columbia, United States, 20007
United States, Florida
Novo Nordisk Investigational Site
Miami, Florida, United States, 33136
United States, Georgia
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30322
United States, Illinois
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60612
United States, New Jersey
Novo Nordisk Investigational Site
Newark, New Jersey, United States, 07103
United States, Pennsylvania
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19107
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75246
Novo Nordisk Investigational Site
Plano, Texas, United States, 75093
United States, Virginia
Novo Nordisk Investigational Site
Charlottesville, Virginia, United States, 22908
Novo Nordisk Investigational Site
Richmond, Virginia, United States, 23298-0541
United States, Washington
Novo Nordisk Investigational Site
Seattle, Washington, United States, 98104-2499
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00102037     History of Changes
Other Study ID Numbers: F7SPIN-2180
First Submitted: January 19, 2005
First Posted: January 20, 2005
Last Update Posted: January 13, 2017
Last Verified: January 2017

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