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Use of Activated Recombinant FVII in Spinal Surgery

This study has been completed.
Information provided by:
Novo Nordisk A/S Identifier:
First received: January 19, 2005
Last updated: June 26, 2012
Last verified: January 2012
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: activated recombinant human factor VII
Phase 2

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

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

Primary Outcome Measures:
  • Safety variables [ Time Frame: Within 30 days after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy variables [ Designated as safety issue: No ]

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)

Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00102037

Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Christine Grier Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S Identifier: NCT00102037     History of Changes
Other Study ID Numbers: F7SPIN-2180 
Study First Received: January 19, 2005
Last Updated: June 26, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders processed this record on October 21, 2016