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Use of Activated Recombinant FVII in Spinal Surgery

Primary Purpose

Acquired Bleeding Disorder, Spinal Fusion

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
eptacog alfa (activated)
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acquired Bleeding Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Outcomes

Primary Outcome Measures

Safety variables

Secondary Outcome Measures

Efficacy variables

Full Information

First Posted
January 19, 2005
Last Updated
January 12, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00102037
Brief Title
Use of Activated Recombinant FVII in Spinal Surgery
Official Title
Evaluation of Safety of Activated Recombinant FVII as an Add-On Therapy in Spinal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Bleeding Disorder, Spinal Fusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
eptacog alfa (activated)
Other Intervention Name(s)
activated recombinant human factor VII
Primary Outcome Measure Information:
Title
Safety variables
Time Frame
Within 30 days after surgery
Secondary Outcome Measure Information:
Title
Efficacy variables

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0728
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0541
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104-2499
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17906567
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). 2007 Oct 1;32(21):2285-93. doi: 10.1097/BRS.0b013e3181557d45.
Results Reference
result
PubMed Identifier
18580208
Citation
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.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

Use of Activated Recombinant FVII in Spinal Surgery

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