ClinicalTrials.gg
CompletedNCT00102037Updated Jan 13, 2017

Use of Activated Recombinant FVII in Spinal Surgery

A Phase 2 interventional study of eptacog alfa (activated) in Acquired Bleeding Disorder and Spinal Fusion, sponsored by Novo Nordisk A/S. Completed at 14 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-01-13.

Sponsored by Novo Nordisk A/S · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Acquired Bleeding Disorder
  • Spinal Fusion
03

In context

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,400 studies on the registry; 102 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 98 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Elective spinal fusion surgery.

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
50 participants (actual)

Interventions

06

What researchers measure

Primary outcomes

  1. Safety variables

    Time frame: Within 30 days after surgery

Secondary outcomes

  1. Efficacy variables

07

Study locations

14 sites
  • Novo Nordisk Investigational Site
    Sacramento, California 95817, United States
  • Novo Nordisk Investigational Site
    San Francisco, California 94143-0728, United States
  • Novo Nordisk Investigational Site
    Washington D.C., District of Columbia 20007, United States
  • Novo Nordisk Investigational Site
    Miami, Florida 33136, United States
  • Novo Nordisk Investigational Site
    Atlanta, Georgia 30322, United States
  • Novo Nordisk Investigational Site
    Chicago, Illinois 60612, United States
  • Novo Nordisk Investigational Site
    Newark, New Jersey 07103, United States
  • Novo Nordisk Investigational Site
    Philadelphia, Pennsylvania 19107, United States
  • Novo Nordisk Investigational Site
    Pittsburgh, Pennsylvania 15213, United States
  • Novo Nordisk Investigational Site
    Dallas, Texas 75246, United States
  • Novo Nordisk Investigational Site
    Plano, Texas 75093, United States
  • Novo Nordisk Investigational Site
    Charlottesville, Virginia 22908, United States
  • Novo Nordisk Investigational Site
    Richmond, Virginia 23298-0541, United States
  • Novo Nordisk Investigational Site
    Seattle, Washington 98104-2499, United States
08

References and documents

Publications

  • 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. PubMed 17906567 ↗
  • 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. PubMed 18580208 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00102037
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Jan 20, 2005
Start date
Jul 2004
Primary completion
Feb 2006
Completion
Feb 2006
Last update
Jan 13, 2017

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Recombinant FVIIa

Start the discussion