Use of Activated Recombinant FVII in Spinal Surgery

NCT ID: NCT00102037

Last Updated: 2017-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2006-02-28

Brief Summary

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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

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Conditions

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Acquired Bleeding Disorder Spinal Fusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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eptacog alfa (activated)

Intervention Type DRUG

Other Intervention Names

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activated recombinant human factor VII

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Sacramento, California, United States

Site Status

Novo Nordisk Investigational Site

San Francisco, California, United States

Site Status

Novo Nordisk Investigational Site

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

Site Status

Novo Nordisk Investigational Site

Miami, Florida, United States

Site Status

Novo Nordisk Investigational Site

Atlanta, Georgia, United States

Site Status

Novo Nordisk Investigational Site

Chicago, Illinois, United States

Site Status

Novo Nordisk Investigational Site

Newark, New Jersey, United States

Site Status

Novo Nordisk Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Novo Nordisk Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

Novo Nordisk Investigational Site

Dallas, Texas, United States

Site Status

Novo Nordisk Investigational Site

Plano, Texas, United States

Site Status

Novo Nordisk Investigational Site

Charlottesville, Virginia, United States

Site Status

Novo Nordisk Investigational Site

Richmond, Virginia, United States

Site Status

Novo Nordisk Investigational Site

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 17906567 (View on PubMed)

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.

Reference Type RESULT
PMID: 18580208 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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F7SPIN-2180

Identifier Type: -

Identifier Source: org_study_id

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