NCT00102037

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2004

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 20, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

January 13, 2017

Status Verified

January 1, 2017

Enrollment Period

1.6 years

First QC Date

January 19, 2005

Last Update Submit

January 12, 2017

Conditions

Acquired Bleeding DisorderSpinal Fusion

Outcome Measures

Primary Outcomes (1)

  • Safety variables

    Within 30 days after surgery

Secondary Outcomes (1)

  • Efficacy variables

Interventions

eptacog alfa (activated)DRUG
Also known as: activated recombinant human factor VII

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective spinal fusion surgery.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Novo Nordisk Investigational Site

Sacramento, California, 95817, United States

Location

Novo Nordisk Investigational Site

San Francisco, California, 94143-0728, United States

Location

Novo Nordisk Investigational Site

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

Location

Novo Nordisk Investigational Site

Miami, Florida, 33136, United States

Location

Novo Nordisk Investigational Site

Atlanta, Georgia, 30322, United States

Location

Novo Nordisk Investigational Site

Chicago, Illinois, 60612, United States

Location

Novo Nordisk Investigational Site

Newark, New Jersey, 07103, United States

Location

Novo Nordisk Investigational Site

Philadelphia, Pennsylvania, 19107, United States

Location

Novo Nordisk Investigational Site

Pittsburgh, Pennsylvania, 15213, United States

Location

Novo Nordisk Investigational Site

Dallas, Texas, 75246, United States

Location

Novo Nordisk Investigational Site

Plano, Texas, 75093, United States

Location

Novo Nordisk Investigational Site

Charlottesville, Virginia, 22908, United States

Location

Novo Nordisk Investigational Site

Richmond, Virginia, 23298-0541, United States

Location

Novo Nordisk Investigational Site

Seattle, Washington, 98104-2499, United States

Location

Related Publications (2)

  • 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.

    PMID: 17906567RESULT

  • 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.

    PMID: 18580208RESULT

Related Links

MeSH Terms

Interventions

Factor VII

Intervention Hierarchy (Ancestors)

Enzyme PrecursorsEnzymes and CoenzymesBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsProtein PrecursorsBiological Factors

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2005

First Posted

January 20, 2005

Study Start

July 1, 2004

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

January 13, 2017

Record last verified: 2017-01

Locations

US(14)