Use of Activated Recombinant FVII in Spinal Surgery

Phase 2

Completed

• Conditions: Acquired Bleeding Disorder; Spinal Fusion

• Registration Number: NCT00102037
• Lead Sponsor: Novo Nordisk A/S

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 and blood transfusions in patients undergoing spinal fusion surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-01-19
• Study First Submitted QC: 2005-01-19
• Study First Posted: 2005-01-20
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-12
• Last Update Posted: 2017-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety variables	Within 30 days after surgery

Secondary Outcome Measures

Name	Time	Method
Efficacy variables

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Seattle, Washington, United States