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NCT00102037 Clinical Trial

Use of Activated Recombinant FVII in Spinal Surgery

Spinal Fusion Clinical Trial

Official title:
Evaluation of Safety of Activated Recombinant FVII as an Add-On Therapy in Spinal Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00102037
Other study ID # F7SPIN-2180
Secondary ID
Status Completed
Phase Phase 2
First received January 19, 2005
Last updated January 12, 2017
Start date July 2004
Est. completion date February 2006

Study information
Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date February 2006
Est. primary completion date February 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• eptacog alfa (activated)

Locations
Country Name City State
United States Novo Nordisk Investigational Site Atlanta Georgia
United States Novo Nordisk Investigational Site Charlottesville Virginia
United States Novo Nordisk Investigational Site Chicago Illinois
United States Novo Nordisk Investigational Site Dallas Texas
United States Novo Nordisk Investigational Site Miami Florida
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 Plano Texas
United States Novo Nordisk Investigational Site Richmond Virginia
United States Novo Nordisk Investigational Site Sacramento California
United States Novo Nordisk Investigational Site San Francisco California
United States Novo Nordisk Investigational Site Seattle Washington
United States Novo Nordisk Investigational Site Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & Publications (2)

Hsia CC, Chin-Yee IH, McAlister VC. Use of recombinant activated factor VII in patients without hemophilia: a meta-analysis of randomized control trials. Ann Surg. 2008 Jul;248(1):61-8. doi: 10.1097/SLA.0b013e318176c4ec. — View Citation

Sachs B, Delacy D, Green J, Graham RS, Ramsay J, Kreisler N, Kruse P, Khutoryansky N, Hu SS. Recombinant activated factor VII in spinal surgery: a multicenter, randomized, double-blind, placebo-controlled, dose-escalation trial. Spine (Phila Pa 1976). 200 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Safety variables Within 30 days after surgery
Secondary Efficacy variables
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