Status:

COMPLETED

Use of Activated Recombinant FVII in Spinal Surgery

Lead Sponsor:

Novo Nordisk A/S

Conditions:

Acquired Bleeding Disorder

Spinal Fusion

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

Brief 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 a...

Eligibility Criteria

Inclusion

  • Elective spinal fusion surgery.

Exclusion

  • 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

Key Trial Info

Start Date :

July 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2006

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT00102037

Start Date

July 1 2004

End Date

February 1 2006

Last Update

January 13 2017

Active Locations (14)

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Page 1 of 4 (14 locations)

1

Novo Nordisk Investigational Site

Sacramento, California, United States, 95817

2

Novo Nordisk Investigational Site

San Francisco, California, United States, 94143-0728

3

Novo Nordisk Investigational Site

Washington D.C., District of Columbia, United States, 20007

4

Novo Nordisk Investigational Site

Miami, Florida, United States, 33136