Use of Activated Recombinant FVII in Spinal Surgery

Completed · Phase 2

Conditions studied: Acquired Bleeding Disorder, Spinal Fusion

In brief

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.

Key facts

Study ID

NCT00102037

Run by

Novo Nordisk A/S

People needed

50

Starts

2004-07-01

Expected to finish

2006-02-01

Last updated by the study team

2017-01-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Elective spinal fusion surgery.

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Sacramento, California, United States
• Novo Nordisk Investigational Site — San Francisco, California, United States
• Novo Nordisk Investigational Site — Washington D.C., District of Columbia, United States
• Novo Nordisk Investigational Site — Miami, Florida, United States
• Novo Nordisk Investigational Site — Atlanta, Georgia, United States
• Novo Nordisk Investigational Site — Chicago, Illinois, United States
• Novo Nordisk Investigational Site — Newark, New Jersey, United States
• Novo Nordisk Investigational Site — Philadelphia, Pennsylvania, United States
• Novo Nordisk Investigational Site — Pittsburgh, Pennsylvania, United States
• Novo Nordisk Investigational Site — Dallas, Texas, United States
• Novo Nordisk Investigational Site — Plano, Texas, United States
• Novo Nordisk Investigational Site — Charlottesville, Virginia, United States
• Novo Nordisk Investigational Site — Richmond, Virginia, United States
• Novo Nordisk Investigational Site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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