Use of Activated Recombinant FVII in Spinal Surgery

This study has been completed.

First Received: January 19, 2005 Last Updated: June 19, 2007 History of Changes

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00102037

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
Spinal Fusion	Drug: activated recombinant human factor VII	Phase II

MedlinePlus related topics: Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study
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:

Primary Outcome Measures:

Safety variables [ Time Frame: Within 30 days after surgery ]

Secondary Outcome Measures:

Efficacy variables

Estimated Enrollment:	48
Study Start Date:	July 2004

Eligibility

Ages Eligible for Study:	15 Years to 70 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102037

Locations

United States, California
Novo Nordisk Clinical Trial Call Center
San Francisco, California, United States, 94143-0728
United States, Delaware
Novo Nordisk Clinical Trial Call Center
Newark, Delaware, United States, 19713
United States, District of Columbia
Novo Nordisk Clinical Trial Call Center
Washington, District of Columbia, United States, 20007
United States, Georgia
Novo Nordisk Clinical Trial Call Center
Atlanta, Georgia, United States, 30339
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Pittsburgh, Pennsylvania, United States, 15213
Novo Nordisk Clinical Trial Call Center
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75230
Novo Nordisk Clinical Trial Call Center
Plano, Texas, United States, 75093
United States, Virginia
Novo Nordisk Clinical Trial Call Center
Richmond, Virginia, United States, 23249
Novo Nordisk Clinical Trial Call Center
Charlottesville, Virginia, United States, 22903
United States, Washington
Novo Nordisk Clinical Trial Call Center
Seattle, Washington, United States, 98104

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Christine Grier

Novo Nordisk

More Information

No publications provided

Study ID Numbers:	F7SPIN-2180
Study First Received:	January 19, 2005
Last Updated:	June 19, 2007
ClinicalTrials.gov Identifier:	NCT00102037 History of Changes
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 07, 2009